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BioHorizons

Also known as: BioHorizons, Inc., BioHorizons Camlog

A United States implant brand within Henry Schein’s Global Oral Reconstruction Group, known for its Laser-Lok surface treatment.

Key facts

ManufacturerHenry Schein, Inc.Verified spec[1][2][3]
Parent companyHenry Schein, Inc., Melville, New YorkVerified spec[1]
CountryUnited StatesVerified spec[4]
HeadquartersManufacturer documentation not located(BioHorizons states that it manufactures in the United States; we have not confirmed a specific address from a primary source)
Founded1994, out of research at the University of Alabama at Birmingham, by Carl E. Misch, Martha Bidez and Todd StrongVerified spec[4]
OwnershipOwned by Henry Schein, which acquired BioHorizons in 2014. Since 2016 BioHorizons and Camlog have been operated together under the Global Oral Reconstruction Group, adopting a joint BioHorizons Camlog identity in 2019Verified spec[1][2]
SurfaceLaser-Lok, a laser-produced microchannel surface treatment applied to the implant collarManufacturer-reported[4]
Geographic availabilityManufactured in the United States and sold in more than 90 countriesManufacturer-reported[4]

Overview

BioHorizons is an American brand that began in 1994 from university research in Alabama and is now owned by Henry Schein — the same owner as Camlog, which is the fact most often lost. The two were brought together in 2016 and share a joint identity, but they were not merged into one product line, so their implants and components remain separate. The brand is closely associated with Laser-Lok, a laser-textured collar surface; that is a genuine and distinctive manufacturing process, though claims about what it achieves for soft tissue and bone are a separate matter requiring clinical evidence rather than the manufacturer’s description.

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 →

FDA 510(k) clearance12 records

Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.

NumberDeviceHolderDate
K223697MRI compatibility for existing BioHorizons dental implants and abutmentsBioHorizons Implant Systems, Inc.2023-10-13
K182070BioHorizons Tapered IM ImplantsBioHorizons Implant Systems, Inc.2018-10-10
K172576BioHorizons Tapered Short ImplantsBioHorizons Implant Systems, Inc.2017-11-22
K143022BioHorizons Tapered Internal ImplantsBioHorizons Implant Systems, Inc.2015-01-08
K121787BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTSBioHorizons Implant Systems, Inc.2012-09-05
K093321BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEMBioHorizons Implant Systems, Inc.2010-04-02
K073282BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEMBioHorizons Implant Systems, Inc.2008-02-15
K073268BIOHORIZONS INTERNAL IMPLANT SYSTEMBioHorizons Implant Systems, Inc.2008-02-08
K071638BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEMBioHorizons Implant Systems, Inc.2007-10-10
K053152BIOHORIZONS SINGLE-STAGE IMPLANTBioHorizons Implant Systems, Inc.2005-12-02
K964330BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)BioHorizons Implant Systems, Inc.1997-01-17
K960026BIOHORIZONS DENTAL IMPLANT SYSTEMBioHorizons Implant Systems, Inc.1996-03-28

Other1 record

Of 100 records we inspected, 100 are supplied sterile, 0 are supplied non-sterile and 0 do not state it. MRI safety labelling: MR Conditional (81); Labeling does not contain MRI Safety Information (19). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.

NumberDeviceHolderDate
351 device records—BioHorizons—

Clearance records for BioHorizons 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 BioHorizons.

Sources

Numbers match the citations beside each claim above.

Primary sources

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