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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 24 of 37

Device	Model / Reference	Registries	Class	Status
BioHorizons	CGS-DGY28	FDA UDI	Class I	Active
BioHorizons	PGHA18L	FDA UDI	Class II	Active
BioHorizons	PXMUPSD	FDA UDI	Class II	Active
BioHorizons	134-350	FDA UDI	Class I	Active
BioHorizons	CTA4215	FDA UDI	Class II	Active
BioHorizons	265-002	FDA UDI	Class II	Unknown
BioHorizons	TSD4025HD	FDA UDI	Class I	Active
BioHorizons	SBPHC55	FDA UDI	Class I	Active
BioHorizons	TMR3812	FDA UDI	Class II	Active
BioHorizons	TRX3415	FDA UDI	Class II	Active
BioHorizons	PBMU173	FDA UDI	Class II	Active
BioHorizons	CTA4607	FDA UDI	Class II	Active
BioHorizons	PYRSC	FDA UDI	Class I	Active
BioHorizons	BC2254.3330	FDA UDI	Class II	Active
BioHorizons	CGS-2817	FDA UDI	Class I	Active
BioHorizons	400-260	FDA UDI	Class II	Active
BioHorizons	BTR3815	FDA UDI	Class II	Active
BioHorizons	SBAA	FDA UDI	Class II	Active
BioHorizons	TLXP5809	FDA UDI	Class II	Active
BioHorizons	PBREA	FDA UDI	Class II	Active
BioHorizons	10821/2907	FDA UDI	Class II	Active
BioHorizons	PYCTA1L	FDA UDI	Class II	Unknown
BioHorizons	TP3SSHM1T	FDA UDI	Class II	Active
BioHorizons	204-604	FDA UDI	Class II	Unknown
BioHorizons	PD-15	FDA UDI	Class I	Active
BioHorizons	TTLB5809	FDA UDI	Class II	Active
BioHorizons	BTR3810	FDA UDI	Class II	Active
BioHorizons	MDLAA15Z	FDA UDI	Class II	Active
BioHorizons	CNTE2S	FDA UDI	Class II	Active
BioHorizons	CGS-2824SU	FDA UDI	Class I	Active
BioHorizons	CTR4207	FDA UDI	Class II	Active
BioHorizons	TMR4612	FDA UDI	Class II	Active
BioHorizons	TDG2034HD	FDA UDI	Class I	Active
BioHorizons	CTA3809R	FDA UDI	Class II	Active
BioHorizons	TSK2021	FDA UDI	Class I	Unknown
BioHorizons	122-232	FDA UDI	Class I	Active
BioHorizons	SGCD50	FDA UDI	Class I	Unknown
BioHorizons	TST2030HD	FDA UDI	Class I	Active
BioHorizons	PBNHA5L	FDA UDI	Class II	Active
BioHorizons	ODSCET	FDA UDI	Class I	Unknown
BioHorizons	PROCDGY	FDA UDI	Class I	Active
BioHorizons	PGODSK1	FDA UDI	Class II	Active
BioHorizons	HD-MAN	FDA UDI	Class I	Active
BioHorizons	PXMUAR	FDA UDI	Class I	Active
BioHorizons	C2273.3820	FDA UDI	Class II	Active
BioHorizons	MDL2015SZ	FDA UDI	Class II	Active
BioHorizons	NB-SEA3WPL	FDA UDI	Class II	Unknown
BioHorizons	BCIW	FDA UDI	Class I	Active
BioHorizons	TP3SEA	FDA UDI	Class II	Active
BioHorizons	122-104	FDA UDI	Class I	Unknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.