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Brånemark System

Also known as: Branemark System, Brånemark, Nobel Biocare Brånemark System

The original two-stage titanium implant line commercialised by Nobel Biocare, built around an external hexagon connection and still catalogued alongside the company’s newer systems.

Research in progress. Some fields on this entry are not yet verified against a primary source, so we have left them blank rather than filling them in — and this page is not published to search engines until they are.

Quick facts

Current statusStill listed as available in the Nobel Biocare implant catalogue, with 24 options, at the date of access.Manufacturer-reported[1][2]We looked specifically for a discontinuation notice and did not find one; the line remains catalogued, though it is a legacy design.
Implant levelManufacturer documentation not located
Body geometryManufacturer documentation not located
Thread designManufacturer documentation not located
Apex designManufacturer documentation not located
MaterialManufacturer documentation not located
SurfaceManufacturer documentation not located(The catalogue page groups Brånemark System products with TiUnite; the original machined-surface implants are of historical rather than current interest.)
ConnectionExternal hexagon. The Nobel Biocare catalogue lists an External hex connection filter covering 93 options, under which the Brånemark System products appear.Manufacturer-reported[1][2]
Platform switchingNot publicly verified(An external hex platform is not platform-switched by design; a narrower abutment can nonetheless be selected.)
Available diametersManufacturer documentation not located(The catalogue page shows several platform designations (NP, RP, WP) but we did not obtain a manufacturer table enumerating diameters, so none are recorded here.)
Available lengthsManufacturer documentation not located

Overview

The Brånemark System is the line that established the two-stage, submerged protocol on which most modern implant dentistry is built, and it remains catalogued by Nobel Biocare rather than withdrawn. Its defining technical feature is the external hexagon: a small hex sitting proud of the implant platform, which was the industry norm for decades and is now uncommon in new designs. For a patient, the relevance is almost entirely about repair — external hex components are still obtainable, but they are not interchangeable with the internal conical connection used across Nobel’s current range. We have deliberately not recorded diameters and lengths here because we could not obtain a manufacturer table for the current catalogue, and reconstructing them from resellers would risk publishing figures that do not match what is actually supplied.

Technology

Clinical positioning

What the manufacturer says this system is designed for. This is not the same thing as independent clinical evidence, which is set out separately below.

Manufacturer documentation not located

Clinical evidence

We have not yet completed a system-specific evidence review for Brånemark System. Insufficient system-specific evidence How we grade evidence

Similar implant systems

The clearances below are held by Nobel Biocare at brand level and cover its implant range, not Brånemark System specifically. We show them here because that is the level at which regulators actually issue them.

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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