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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 20 of 37

Device	Model / Reference	Registries	Class	Status
BioHorizons	CGS2500	FDA UDI	Class I	Unknown
BioHorizons	5009D3	FDA UDI	Class II	Unknown
BioHorizons	MDL2010Z	FDA UDI	Class II	Active
BioHorizons	PYBPA	FDA UDI	Class II	Active
BioHorizons	PYWHA5L	FDA UDI	Class II	Active
BioHorizons	TSD2025	FDA UDI	Class I	Unknown
BioHorizons	PGTBLS	FDA UDI	Class I	Active
BioHorizons	PGMU2L	FDA UDI	Class II	Active
BioHorizons	BCAS	FDA UDI	Class I	Active
BioHorizons	PGRAA	FDA UDI	Class II	Active
BioHorizons	122-12515	FDA UDI	Class I	Active
BioHorizons	TSD2041HDSU	FDA UDI	Class I	Active
BioHorizons	222-110	FDA UDI	Class I	Active
BioHorizons	6012D3	FDA UDI	Class II	Unknown
BioHorizons	SB-GY-8	FDA UDI	Class I	Active
BioHorizons	TIM8010	FDA UDI	Class II	Active
BioHorizons	TST2038HD	FDA UDI	Class I	Active
BioHorizons	TD-25	FDA UDI	Class I	Active
BioHorizons	PBWHA5	FDA UDI	Class II	Active
BioHorizons	SBPWSC	FDA UDI	Class I	Active
BioHorizons	AFS354	FDA UDI	Class II	Unknown
BioHorizons	160-200	FDA UDI	Class I	Unknown
BioHorizons	PB5508L	FDA UDI	Class II	Active
BioHorizons	PGRHA2	FDA UDI	Class II	Active
BioHorizons	TDS42SB	EUDAMEDFDA UDI	Class I	Active
BioHorizons	TP3WHA3	FDA UDI	Class II	Active
BioHorizons	GS-GC-P	FDA UDI	Class I	Active
Biohorizons	PXBZ	FDA UDI	Class I	Active
BioHorizons	LPBR60105	FDA UDI	Class II	Unknown
BioHorizons	SBHA40	FDA UDI	Class II	Active
BioHorizons	PG5508L	FDA UDI	Class II	Active
BioHorizons	PGPCAN	FDA UDI	Class II	Unknown
BioHorizons	TSD202509HD	FDA UDI	Class I	Active
BioHorizons	TIMD8007	FDA UDI	Class I	Active
BioHorizons	TA-GY-PN	FDA UDI	Class II	Active
BioHorizons	TD-2510	FDA UDI	Class I	Active
BioHorizons	TLX3809	FDA UDI	Class II	Active
BioHorizons	TP3SSHA1	FDA UDI	Class II	Active
BioHorizons	BHEXZ	FDA UDI	Class II	Active
BioHorizons	CA-YW-A20	FDA UDI	Class II	Active
BioHorizons	PGHYB	FDA UDI	Class II	Active
BioHorizons	234-215	FDA UDI	Class II	Unknown
BioHorizons	TLR5815	FDA UDI	Class II	Active
BioHorizons	TLX4610	FDA UDI	Class II	Active
BioHorizons	MU-HAH	FDA UDI	Class I	Active
BioHorizons	GD-4121	FDA UDI	Class I	Active
BioHorizons	CC-YW-H	FDA UDI	Class II	Active
BioHorizons	PYMU173	FDA UDI	Class II	Active
BioHorizons	BC2255.33TRY	FDA UDI	Class I	Active
BioHorizons	PXABSL	FDA UDI	Class II	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.