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BIOHORIZONS IMPLANT SYSTEMS INC.

United States·US-MF-000014002

Last updated September 17, 2026

What BIOHORIZONS IMPLANT SYSTEMS INC. makes

BioHorizons Implant Systems Inc. manufactures dental implant suprastructures, both permanent and temporary preformed types, as well as two-piece screw endosteal dental implants. The company also produces reusable and single-use dental drill bits, resilient dental precision attachments, reusable dental implantation depth/angle gauges, and reusable surgical screwdrivers.

The devices are classified as Class I and Class II medical devices and are listed in the EUDAMED and FDA UDI registries. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does BioHorizons Implant Systems Inc. make?

Where is BioHorizons Implant Systems Inc. based?

BioHorizons Implant Systems Inc. is based in the United States, as stated in the provided device data under the COUNTRY field.

Which registries list BioHorizons Implant Systems Inc.'s devices?

The devices manufactured by BioHorizons Implant Systems Inc. are listed in the EUDAMED and FDA UDI registries, as indicated in the LISTED IN field of the device data.

How are BioHorizons Implant Systems Inc.'s devices classified?

The devices manufactured by BioHorizons Implant Systems Inc. are classified as Class I and Class II medical devices, according to the DEVICE CLASSES field in the provided data.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 2300, Riverchase Center, Birmingham, United States
Website: www.biohorizons.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 (205) 968-7994
PRRC Contact: Jared Cooper
EUDAMED SRN: US-MF-000014002
FDA FEI Number: 1000592496
DUNS Number: —

Catalogue (1836)

Page 37 of 37

Device	Model / Reference	Registries	Class	Status
Biohorizons Ceramic Abutment	K061567	FDA 510(k)	Class II	Active
Biohorizons Tapered Internal Plus Implants	K121787	FDA 510(k)	Class II	Active
Maximus 3.0 And Os Implants	K052419	FDA 510(k)	Class II	Active
Modification To The Maestro System	K022795	FDA 510(k)	Class II	Active
Biohorizons Abutments For Zimmer	K103691	FDA 510(k)	Class II	Active
Biohorizons Dental Implant System (name Subject To Change)	K964330	FDA 510(k)	Class II	Active
The Prodigy System Dental Implants	K042429	FDA 510(k)	Class II	Active
BioHorizons CAD/CAM Bars	K180998	FDA 510(k)	Class II	Active
Biohorizons Simple Solutions With Laser-Lok	K100985	FDA 510(k)	Class II	Active
The Autotac System Titanium Tack	K022790	FDA 510(k)	Class II	Active
Modification To The Maestro System	K020645	FDA 510(k)	Class II	Active
Biohorizons Dental Implant System	K960026	FDA 510(k)	Class II	Active
SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment	K240531	FDA 510(k)	Class II	Active
BioHorizons Tapered Internal Implants	K143022	FDA 510(k)	Class II	Active
Tapered Pro Conical Implant System	K240187	FDA 510(k)	Class II	Active
BioHorizons Tapered Short Implants	K172576	FDA 510(k)	Class II	Active
Biohorizons Single-Stage Implant System	K073282	FDA 510(k)	Class II	Active
Biolok Micro-Lok Implant System	K081818	FDA 510(k)	Class II	Active
Maximus Os (overdenture System)	K041938	FDA 510(k)	Class II	Active
Biohorizons Tapered Internal Implant System	K071638	FDA 510(k)	Class II	Active
Biohorizons Single-Stage Implant	K053152	FDA 510(k)	Class II	Active
As 123 Prosthetic Instrumentation System	K963951	FDA 510(k)	Class II	Active
The Maestro System	K010458	FDA 510(k)	Class II	Active
BioHorizons CAD/CAM Abutments	K151621	FDA 510(k)	Class II	Active
Conical Ti Base abutments	K243521	FDA 510(k)	Class II	Active
Biohorizons Laser-Lok Abutments For Nobel Biocare	K103291	FDA 510(k)	Class II	Active
Biohorizons Plastic Temporary Abutments	K053099	FDA 510(k)	Class II	Active
Implant Site Dilators	K980374	FDA 510(k)	Class II	Active
MRI compatibility for existing BioHorizons dental implants and abutments	K223697	FDA 510(k)	Class II	Active
BioHorizons Tapered IM Implants	K182070	FDA 510(k)	Class II	Active
Biohorizons Laser-Lok 3.0 Implant System	K093321	FDA 510(k)	Class II	Active
Modification To The Maestro System	K020133	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Biohorizons Internal Implant System	K073268	FDA 510(k)	Class II	Active
The Autotac System	K011675	FDA 510(k)	Class II	Active
Modification To The Maestro System	K030463	FDA 510(k)	Class II	Active
The Autotac System	K993493	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

There are 6 recall records for BioHorizons Implant Systems Inc., with the earliest initiated on September 7, 2010, and the most recent initiated on October 30, 2015. All records are listed with a status of terminated. The reasons given include insufficient cleaning instructions to remove residual contaminants after surgical use, an incorrect stainless steel drill component packaged in place of the correct titanium component in the Tapered HD Upgrade set, a body length discrepancy where the External Implant 40105D3 Lot 1302762 labeled as 10.5mm is actually 12mm, an incorrect label reading 10.5mm instead of the specified 15mm on implant inner vial packaging, and a healing abutment that may not fully seat on the implant.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Oct 30, 2015	Z-0391-2016	—	terminated	An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
Apr 16, 2015	Z-1605-2015	—	terminated	BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.
Dec 10, 2013	Z-1058-2014	—	terminated	The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.
Nov 19, 2012	Z-0561-2013	—	terminated	The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.
Nov 19, 2012	Z-0562-2013	—	terminated	The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.
Sep 7, 2010	Z-0321-2011	—	terminated	Healing abutment may not fully seat on the implant.