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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 31 of 37

Device	Model / Reference	Registries	Class	Status
BioHorizons	TP3RATA	FDA UDI	Class II	Active
BioHorizons	133-100	FDA UDI	Class I	Unknown
BioHorizons	CTA3815	FDA UDI	Class II	Active
BioHorizons	BC2257.4330	FDA UDI	Class II	Active
BioHorizons	TP3CMAWX	FDA UDI	Class II	Active
BioHorizons	C2273.5050	FDA UDI	Class II	Active
BioHorizons	TP3ODSK6	FDA UDI	Class II	Active
BioHorizons	SST	FDA UDI	Class I	Unknown
BioHorizons	CA-YW-DP	FDA UDI	Class II	Active
BioHorizons	20821/2907	FDA UDI	Class II	Active
BioHorizons	400-001	FDA UDI	Class I	Active
BioHorizons	TA-GY-TH	FDA UDI	Class II	Active
BioHorizons	CGS-4721SU	FDA UDI	Class I	Active
BioHorizons	TRXP4615	FDA UDI	Class II	Active
BioHorizons	BDBPZ	FDA UDI	Class I	Active
BioHorizons	SGAP40	FDA UDI	Class II	Active
BioHorizons	PBNHA3	FDA UDI	Class II	Active
BioHorizons	PYTTN	FDA UDI	Class II	Active
BioHorizons	300-354	FDA UDI	Class I	Active
BioHorizons	PGAEAL	FDA UDI	Class II	Active
BioHorizons	TA-YW-TN	FDA UDI	Class II	Active
BioHorizons	CTR3815	FDA UDI	Class II	Active
BioHorizons	TP3CC	FDA UDI	Class II	Active
BioHorizons	NB-BPAWPL	FDA UDI	Class II	Unknown
BioHorizons	NB-35964	FDA UDI	Class II	Unknown
BioHorizons	CTA4209	FDA UDI	Class II	Active
BioHorizons	TTLG4612	FDA UDI	Class II	Active
BioHorizons	TTLY3012	FDA UDI	Class II	Active
BioHorizons	PYNEA	FDA UDI	Class II	Active
BioHorizons	PROPRE47	FDA UDI	Class I	Active
BioHorizons	135-451	FDA UDI	Class I	Active
BioHorizons	GD-2528	FDA UDI	Class I	Active
BioHorizons	CLS25	FDA UDI	Class I	Active
BioHorizons	HD-ISO	FDA UDI	Class I	Active
BioHorizons	TIM5RB	FDA UDI	Class I	Active
BioHorizons	PYGBAA	FDA UDI	Class I	Active
BioHorizons	CRSSHA2T	FDA UDI	Class II	Active
BioHorizons	PGHA08L	FDA UDI	Class II	Active
BioHorizons	CGS-4117SU	FDA UDI	Class I	Active
BioHorizons	MU-GY-S1	FDA UDI	Class II	Active
BioHorizons	130-050	FDA UDI	Class II	Unknown
BioHorizons	PGAFS25	FDA UDI	Class II	Active
BioHorizons	TP3HA5	FDA UDI	Class II	Active
BioHorizons	TRX4609	FDA UDI	Class II	Active
BioHorizons	PYCMAWV	FDA UDI	Class II	Active
BioHorizons	C2273.5030	FDA UDI	Class II	Active
BioHorizons	CNICO	FDA UDI	Class I	Active
BioHorizons	TLX5812	FDA UDI	Class II	Active
BioHorizons	CRSSHA2	FDA UDI	Class II	Active
BioHorizons	CNBRC	FDA UDI	Class I	Active

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.