Envista Holdings Corporation (Envista) is a global dental products company.
Envista is a global family of more than 30 trusted dental brands, including Nobel Biocare, Ormco, DEXIS, and Kerr, united by a shared purpose: to partner with professionals to improve lives by digitizing, personalizing and democratizing oral care. The company helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technologies, and services. The company’s divers...
Envista Holdings Corporation (Envista) is a global dental products company.
Envista is a global family of more than 30 trusted dental brands, including Nobel Biocare, Ormco, DEXIS, and Kerr, united by a shared purpose: to partner with professionals to improve lives by digitizing, personalizing and democratizing oral care. The company helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technologies, and services. The company’s diversified portfolio of solutions covers a broad range of dentists' clinical needs for preventing, diagnosing, and treating dental conditions, as well as improving the aesthetics of the human smile. The company offers comprehensive solutions to support implant-based tooth replacements, orthodontic treatments, and diagnostic solutions. The company further supports the dental community with leading solutions in restoratives, endodontics, rotary, infection prevention, and loupes.
With a foundation consisted of the proven Envista Business System (‘EBS’) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus, the company is well equipped to meet the end-to-end needs of dental professionals worldwide. The company is one of the largest global dental products companies, with strong positions in some of the most attractive segments of the dental products industry. The company serves dental professionals in over 130 countries through one of the largest commercial organizations in the dental products industry and through the company’s distribution partners.
Business Segments
The company’s business is operated through two segments: Specialty Products & Technologies, which is consisted of the company’s Implant-Based Tooth Replacement and Orthodontic Solutions businesses; and Equipment & Consumables, which is consisted of the company’s Diagnostic Solutions and Consumables businesses.
Specialty Products & Technologies segment
The company’s Specialty Products & Technologies segment primarily develops, manufactures and markets dental implant systems, including regenerative solutions, dental prosthetics and associated treatment software and technologies, as well as orthodontic bracket systems, aligners and lab products. The company typically markets these products directly to end-users through its commercial organization, and 84% of the company’s 2024 sales for this segment were direct sales. In 2024, 42% of segment sales were derived from North America, 27% from Western Europe, 5% from other developed markets, and 26% from emerging markets. Sales of consumable products, services and spare parts comprised 94% of segment sales in 2024.
Implant-Based Tooth Replacements
The company is a world leader in the field of innovative implant-based tooth replacements offering a full portfolio of solutions that enable dentists to deliver single-tooth to full-mouth restorations. One of the company’s brands, Nobel Biocare, is the pioneer of implant science grounded in clinical research and has introduced a number of innovations that have become widely adopted in the implant industry. The company’s comprehensive product offering includes dental implant systems, guided surgery systems, biomaterials, and prefabricated and custom-built prosthetics. Other well-known brands in the company’s portfolio include Alpha-Bio Tec, Implant Direct, and NobelProcera. The company also offers a comprehensive education program to fully train the company’s broad range of clinical customers, from clinicians performing basic implant procedures to the most advanced practitioners, with the intention of enhancing patient access to high-quality dental care. The company’s customers include oral surgeons, periodontists, prosthodontists, and general dentists.
The company’s Implant-Based Tooth Replacement brands have a long history of innovation, which include both the first documented case of a titanium dental implant being placed in a human and the introduction of the concept of living bone adhering to an artificial implant (known as osseointegration). The company’s Nobel Biocare brand offers several implant systems and is integrating them with the DTX suite of software applications described below. Through the company’s Implant Direct and Alpha-Bio Tec value implant businesses, the company also offers a variety of implant systems that cover a broad range of price points in the market. The company’s Osteogenics acquisition added innovative regenerative solutions that are highly complementary to the implant treatment.
Since being acquired in 2014, Nobel Biocare has focused on reinvigorating its product offerings and has released over 30 new products. Among these are comprehensive software packages which are used for treatment planning of dental implants procedures and prosthetics. These software packages are integrated in the company’s broader DTX software suite, which also includes the ‘DTX Studio Clinic’ software package.
Orthodontic Solutions
The company’s Orthodontic Solutions businesses provide orthodontic professionals with high quality products backed by educational support to enhance the lives of their patients. The company is a leading manufacturer and provider of advanced orthodontic technology and services designed to move malpositioned teeth and jaws. The company’s products include brackets and wires, tubes and bands, clear aligners, digital orthodontic treatments, retainers, and other orthodontic laboratory products, and are marketed under the Ormco, Damon, Insignia, AOA, and Spark brands. The company also offers a comprehensive education system to fully train its clinical customers on the use of the company’s products to address the full range of treatments from basic to the most advanced, with the goal of enhancing patient access to high-quality dental care. Customers of the company’s Orthodontic Solutions business are primarily orthodontists.
The company’s clear aligner system, Spark, is designed for mild to complex malocclusion and is made with TruGEN and TruGEN XR, the latest generation of aligner materials. It is designed to deliver higher sustained force retention for efficiency and a high level of transparency for aesthetics. Spark aligners are also designed with polished, scalloped edges to enhance patient comfort. Over the past three years, the company has launched a suite of upgrades to its Spark clear aligner Approver software designed to improve the customer experience with flexibility and customization features. The company has partnered with industry leading intra-oral scanner companies, including the company’s own DEXIS IOS scanner, as part of its commitment to making imaging integrations seamless. Spark will provide growth opportunities for the company’s Orthodontic Solutions business over the next several years.
Equipment & Consumables segment
The company’s Equipment & Consumables segment primarily develops, manufactures, and markets dental equipment and supplies used in dental offices, including digital imaging systems, software, and other visualization/magnification systems; endodontic systems and related products; restorative materials and instruments, rotary burs, impression materials, bonding agents and cements; and infection prevention products. In 2024, 69% of segment sales were derived from North America, 12% from Western Europe, 4% from other developed markets, and 15% from emerging markets. The company distributes its Equipment & Consumables segment products primarily through the company’s channel partners, representing approximately 88% of sales in this segment in 2024. Sales from consumable products, services and spare parts comprised approximately 69% of segment sales in 2024.
Diagnostic Solutions
The company’s Diagnostic Solutions business is focused on dental imaging, X-ray, and intraoral scanner solutions used in dental offices, clinics and hospitals. The company’s Diagnostic Solutions business was the pioneer in 2D/panoramic and 3D imaging and has one of the largest installed bases of dental imaging devices utilized in dental practices. The company holds a leading position in 3D imaging through the i-CAT and DEXIS brands. The company’s DEXIS brand is an industry leader in intraoral X-Ray digital sensors, which provide two-dimensional images of the mouth. The company’s acquisition of the Intraoral Scanner Business in April 2022 added intraoral scanners and related software to the company’s portfolio.
The ‘DTX Studio Clinic’ software package is offered on many of the company’s imaging products, allowing dental professionals to store and access a broad variety of clinical patient images (e.g., 2D/3D/IOS/pictures) in one place. In combination with the ‘DTX Studio Implant’ and ‘DTX Studio Lab’ software packages, clinicians can use one software ecosystem for image acquisition and diagnosis to treatment planning, implant surgery and restoration planning and placement, as well as for collaboration with treatment partners such as other dentists or laboratories on one digital platform.
Consumables Solutions
The company’s Consumables business markets a broad offering of general dental products that are used in dental offices, clinics and hospitals. The business was primarily established through the acquisition of Sybron Dental Specialties in 2006, as well as numerous other acquisitions. The company’s products are marketed under a variety of brands, including Kerr, Metrex, Total Care, Pentron, Optibond, Harmonize, Sonicfill, Sybron Endo, and CaviWipes.
The company’s products have strong brand and product recognition across many product categories, including restorative, endodontics, and infection control. The company offers several products designed to repair and restore fractured or otherwise damaged teeth. The company also offers cements and bonding agents. The company’s Endodontics business offers a variety of products used in the endodontic workflow, which help clinicians to locate, shape, clean, and fill root canals. The company also produces curing lights and other products including impression materials, burs, and waxes under several brands. Through the company’s Metrex brand, the company has a strong position within infection prevention products, which include the CaviWipes and CaviCide product lines, and are well positioned in both the dental and general medical market segments.
Priorities
The company’s priorities are focused in the following areas:
Growth: The company is investing in commercialization, clinical education, and innovation in the company’s businesses to accelerate growth.
Operations: The company is utilizing EBS to improve manufacturing performance and operating costs.
Strategy
The company’s strategic focus is consisted of three key elements: establishing a strong foundation; reinvesting for growth; and maintaining and pursuing long-term market leadership (such digital workflow, specialty products & technologies, and emerging markets).
International Operations
The company’s products and services are available worldwide, and the company’s principal markets outside the U.S. are in Europe, Asia, the Middle East and Latin America. In 2024, the company generated 52% of the company’s sales in North America, 22% of the company’s sales in Western Europe, 21% of the company’s sales in emerging markets and 5% of the company’s sales in other developed markets.
The company also has operations around the world, and this geographic diversity allows the company to draw on the skills of a worldwide workforce, provides greater stability to the company’s operations, allows the company to drive economies of scale, provides sales streams that may help offset economic trends that are specific to individual economies and offers the company an opportunity to access new markets for products. The company’s future growth depends in part on its ability to continue developing products and sales models that successfully target emerging markets.
Most of the company’s sales in non-U.S. markets are made by its subsidiaries located outside the U.S., though the company also sells from the U.S. into non-U.S. markets through various representatives and distributors, and in some cases, directly. In countries with low sales volumes, the company generally sells through representatives and distributors.
Sales and Distribution
Typical customers and end-users of the company’s products include dental specialists such as orthodontists, periodontists, implantologists and endodontists, general dentists, dental hygienists, oral surgeons, dental laboratories and other oral health professionals, including DSOs, as well as educational, medical and governmental entities and third-party distributors.
The company’s commercial organization includes over 3,000 employees with deep clinical, product and workflow expertise who interact with dental practitioners on a daily basis. Through the company’s trusted brands, innovative product offerings and comprehensive customer service, the company has established strong relationships globally with key constituencies, including DSOs, dental specialists, general dentists, and dental laboratories.
In 2024, the company distributed approximately 42% of the company’s products through third-party distributors. Certain highly technical products, such as dental implant systems, orthodontic appliances, dental laboratory equipment and consumable products, and endodontic instruments and materials, are typically sold directly to dental professionals and dental laboratories.
One customer, Henry Schein, Inc. (‘Henry Schein’), accounted for approximately 10% of the company’s sales for 2024.
While a sizable portion of the company’s sales are derived from distributors, most of the company’s marketing and advertising activities are directed towards the end-users of the company’s products, the dental professional. In addition to the company’s marketing efforts, as noted above, the company conducts significant training and education programs globally for dental professionals to enhance patient access to high-quality dental care. In these programs, the company’s employees and/or experts in the respective clinical fields demonstrate the proper use of the company’s products. The company maintains educational and consulting relationships with key experts who assist the company in developing new products, new indicated uses for the company’s products and educational programs for health care providers and consumers. The company also maintains educational and consulting relationships with dental associations around the world.
Intellectual Property
The company’s products and technologies are protected by over 1,800 granted patents.
Seasonal Nature of Business
General economic conditions impact the company’s business and financial results, and certain of the company’s businesses experience seasonal and other trends related to the end markets and regions that they serve. For example, sales of capital equipment have historically been stronger in the fourth calendar quarter (year ended December 2024).
Regulatory Matters
Most of the company’s products are classified as medical devices and are subject to restrictions under domestic and foreign laws, rules, regulations, self-regulatory codes, circulars and orders, including, but not limited to, the U.S. Food, Drug, and Cosmetic Act (the ‘FDCA’). The FDCA requires these products, when sold in the U.S., to be safe and effective for their intended uses and to comply with the regulations administered by the U.S. Food and Drug Administration (the ‘FDA’). The FDA regulates the design, development, research, preclinical and clinical testing, introduction, manufacture, advertising, labeling, packaging, marketing, distribution, import and export and record keeping for such products. Certain medical device products are also regulated by comparable agencies in non-U.S. countries in which they are produced or sold.
The company’s products are either classified as Class I or Class II devices in the U.S. Most of the company’s Class II and certain of its Class I devices are marketed pursuant to 510(k) pre-marketing clearances. The FDA also enforces additional regulations regarding the safety of X-ray emitting devices that the company markets.
Any medical devices the company manufactures and distributes are subject to pervasive and continuing regulation by the FDA and certain state agencies. These include product listing and establishment registration requirements, which help facilitate FDA inspections and other regulatory actions. As a medical device manufacturer, all of the company’s manufacturing facilities are subject to inspection on a routine basis by the FDA. The company is required to adhere to the Current Good Manufacturing Practices (‘cGMP’) requirements, as set forth in the Quality Systems Regulation (‘QSR’), which require, manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all phases of the design and manufacturing process.
In the European Union (‘EU’), the company’s products are subject to the medical device laws of the various member states, which for many years were based on Directives of the European Commission. Complying with the EU Medical Device Regulation and the evolving regulatory regimes in the U.K. and Switzerland requires modifications to the company’s quality management systems, additional resources in certain functions and updates to technical files, among other changes.
In addition to the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act and similar anti-bribery laws, the company is also subject to various health care related laws regulating fraud and abuse, research and development, pricing and sales and marketing practices and the privacy and security of health information, including the U.S. federal regulations described below. Many states, foreign countries and supranational bodies have also adopted laws and regulations similar to, and in some cases more stringent than, the U.S. federal regulations discussed above and below.
The Federal Anti-Kickback Statute prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration in any form (including any kickback, bribe, or certain rebate), directly or indirectly, to induce or reward the referral of business payable under a government healthcare program, such as Medicare or Medicaid, or in return for the purchase, lease, order, arranging for, or recommendation of items or services covered under a government health care program. A person or entity does not need to have actual knowledge of the statute or specific intent to violate the statute to have committed a violation.
The Health Insurance Portability and Accountability Act of 1996 (‘HIPAA’) prohibits knowingly and willfully (1) executing, or attempting to execute, a scheme to defraud any health care benefit program, including private payors, or (2) falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for health care benefits, items or services. Similar to the Federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the healthcare fraud statute implemented under HIPAA or specific intent to violate the statute to have committed a violation.
The False Claims Act imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by a federal health care program, knowingly makes, uses or causes to be made or used, a false record or statement material to a false or fraudulent claim, or knowingly makes a false statement to avoid, decrease or conceal an obligation to pay money to the U.S. federal government. The qui tam provisions of the False Claims Act allow a private individual to bring actions on behalf of the federal government alleging that the defendant has submitted a false claim to the federal government, and to share in any monetary recovery. In addition, the government may assert that a claim including items and services resulting from a violation of the U.S. Federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act.
The federal Civil Monetary Penalties Law prohibits, among other things, the offering or transferring of remuneration to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular supplier of Medicare or Medicaid payable items or services.
The Open Payments Act requires manufacturers of medical devices covered under Medicare, Medicaid or the Children’s Health Insurance Program, subject to specific exceptions, to record payments and other transfers of value to a broad range of healthcare providers (including dentists) and teaching hospitals and to report this data, as well as ownership and investment interests held by the physicians described above and their immediate family members to the Department of Health and Human Services (‘HHS’) for subsequent public disclosure. Similar reporting requirements have also been enacted on the state level, and an increasing number of countries worldwide either have adopted or are considering similar laws requiring transparency of interactions with health care professionals.
The company is also subject to the General Data Protection Regulation (‘GDPR’), the primary data protection law in the European Economic Area, including the European Union (collectively, the ‘EU’), as well as associated EU member state data protection laws and the UK GDPR in the United Kingdom.
The company’s operations and properties are subject to laws and regulations relating to environmental protection, including those governing air emissions, water discharges and waste management, and workplace health and safety. In addition, certain of the company’s products are regulated by the U.S. Environmental Protection Agency and comparable state regulatory agencies.
The company is required to comply with various U.S. export/import control and economic sanctions laws, including the regulations administered by the U.S. Department of Treasury, Office of Foreign Assets Control, which implement economic sanctions imposed against designated countries, governments and persons based on the U.S. foreign policy and national security considerations, and the import regulatory activities of the U.S. Customs and Border Protection.
History
Envista Holdings Corporation was founded in 2018. The company was incorporated in Delaware in 2018.
