Nobel Biocare
Also known as: Nobelpharma, Nobel Biocare Services AG
The implant brand descended from Per-Ingvar Brånemark’s original titanium implant work, now owned by Envista Holdings.
Key facts
| Manufacturer | Envista Holdings CorporationVerified spec[1][2][3] |
|---|---|
| Parent company | Envista Holdings Corporation, Brea, CaliforniaVerified spec[1] |
| Country | SwitzerlandVerified spec[4] |
| Headquarters | Zurich, Switzerland, with production in the United States, Sweden and JapanVerified spec[4] |
| Founded | Nobelpharma was founded in Gothenburg, Sweden in 1981 and renamed Nobel Biocare in 1996; the underlying work is Per-Ingvar Brånemark’s, who placed the first titanium dental implant in 1965Verified spec[4] |
| Ownership | Owned by Envista Holdings. Danaher Corporation completed its acquisition of Nobel Biocare Holding AG on 11 December 2014, taking about 97% of the shares and moving to delist the company from the SIX Swiss Exchange; Envista was formed inside Danaher in 2018 and separated in 2019, taking Nobel Biocare with itVerified spec[5][1][3]Nobel Biocare’s own timeline dates the Danaher acquisition to 2015; Danaher’s completion release is dated 11 December 2014, with the squeeze-out and delisting following in the first quarter of 2015. The two dates describe different stages of the same transaction. |
| Manufacturer-described indication | Presented as a leading innovator of implant-based dental restorations, and as the group’s premium implant brand alongside the Implant Direct and Alpha-Bio Tec value businessesManufacturer-reported[3][2] |
| manufacturingCountry | Sweden, Netherlands, Switzerland, United StatesVerified spec[6]Country of the FDA-registered device establishment, which may differ from the brand’s home country. |
Overview
Regulatory record
Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →
Other7 records
Registered device establishment in Sweden. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.
| Number | Device | Holder | Date |
|---|---|---|---|
| 9611992 | — | NOBEL BIOCARE AB | — |
| 3006540014 | — | NOBEL BIOCARE DISTRIBUTION CENTER BV | — |
| 3008693672 | — | Nobel Biocare Services AG | — |
| 3005031178 | — | NOBEL BIOCARE PROCERA, LLC | — |
| 2027971 | — | NOBEL BIOCARE USA, LLC | — |
| 9611993 | — | NOBEL BIOCARE AB, PRODUKTION | — |
| 1002 device records | — | Nobel Biocare | — |
FDA 510(k) clearance6 records
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
| Number | Device | Holder | Date |
|---|---|---|---|
| K252197 | Nobel Biocare S Series Implants | Nobel Biocare AB | 2026-02-18 |
| K212125 | Nobel Biocare Dental Implant Systems Portfolio - MR Conditional | Nobel Biocare AG | 2021-09-24 |
| K041661 | NOBEL BIOCARE ENDOSSEOUS IMPLANTS | Nobel Biocare Uas, Inc. | 2004-08-26 |
| K922805 | NOBELPHARMA TORQUE CONTROLLER | Nobelpharma USA, Inc. | 1993-07-22 |
| K910611 | NOBELPHARMA CERAONE ABUTMENT SYSTEM | Nobelpharma USA, Inc. | 1991-08-16 |
| K905436 | NOBELPHARMA DRILLING EQUIPMENT DEC 500 | Nobelpharma USA, Inc. | 1991-03-04 |
Clearance records for Nobel Biocare were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Nobel Biocare.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]Envista Holdings Corporation — Annual Report on Form 10-K for the year ended 31 December 2025 — U.S. Securities and Exchange Commission (EDGAR), 2026. Accessed 2026-07-21.
- [2]Specialty Products & Technology — Envista — Envista Holdings Corporation. Accessed 2026-07-21.
- [3]About us — Nobel Biocare — Nobel Biocare Services AG. Accessed 2026-07-21.
- [4]Our story — Nobel Biocare — Nobel Biocare Services AG. Accessed 2026-07-21.
- [5]Danaher Completes Acquisition Of Nobel Biocare — Danaher Corporation (distributed via PR Newswire), 2014. Accessed 2026-07-21.
- [6]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.