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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

ManufacturerEnvista Holdings CorporationVerified spec[1][2][3]
Parent companyEnvista Holdings Corporation, Brea, CaliforniaVerified spec[1]
CountrySwitzerlandVerified spec[4]
HeadquartersZurich, Switzerland, with production in the United States, Sweden and JapanVerified spec[4]
FoundedNobelpharma 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]
OwnershipOwned 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 indicationPresented 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]
manufacturingCountrySweden, Netherlands, Switzerland, United StatesVerified spec[6]Country of the FDA-registered device establishment, which may differ from the brand’s home country.

Overview

Nobel Biocare carries the oldest lineage in modern implantology — it grew out of Per-Ingvar Brånemark’s discovery of osseointegration and the company Nobelpharma, founded in Gothenburg in 1981 and renamed in 1996 — and it has changed owner more than once since. Its current owner is Envista: Danaher completed the takeover in December 2014, and the business moved to Envista when Envista was carved out of Danaher and separated by public offering in 2019. Nobel Biocare’s own history page dates that takeover to 2015, which is the year the squeeze-out and Swiss delisting completed rather than a different transaction. The heritage is often used in marketing as though it transferred to every product in the range, which it does not: the original Brånemark implant is a specific machined-surface design, while the modern catalogue is dominated by newer systems with different surfaces and connections.

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.

NumberDeviceHolderDate
9611992NOBEL BIOCARE AB
3006540014NOBEL BIOCARE DISTRIBUTION CENTER BV
3008693672Nobel Biocare Services AG
3005031178NOBEL BIOCARE PROCERA, LLC
2027971NOBEL BIOCARE USA, LLC
9611993NOBEL BIOCARE AB, PRODUKTION
1002 device recordsNobel 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.

NumberDeviceHolderDate
K252197Nobel Biocare S Series ImplantsNobel Biocare AB2026-02-18
K212125Nobel Biocare Dental Implant Systems Portfolio - MR ConditionalNobel Biocare AG2021-09-24
K041661NOBEL BIOCARE ENDOSSEOUS IMPLANTSNobel Biocare Uas, Inc.2004-08-26
K922805NOBELPHARMA TORQUE CONTROLLERNobelpharma USA, Inc.1993-07-22
K910611NOBELPHARMA CERAONE ABUTMENT SYSTEMNobelpharma USA, Inc.1991-08-16
K905436NOBELPHARMA DRILLING EQUIPMENT DEC 500Nobelpharma 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

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