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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 33 of 37

Device	Model / Reference	Registries	Class	Status
BioHorizons	NB-RPSA	FDA UDI	Class I	Unknown
BioHorizons	MDL2013SZ	FDA UDI	Class II	Active
BioHorizons	CGS-3217SU	FDA UDI	Class I	Active
BioHorizons	CR17MU3	FDA UDI	Class II	Active
BioHorizons	PYODS2	FDA UDI	Class II	Active
BioHorizons	PYWHA5	FDA UDI	Class II	Active
BioHorizons	PGTBL	FDA UDI	Class II	Active
BioHorizons	TIM8007	FDA UDI	Class II	Active
BioHorizons	126-000	FDA UDI	Class I	Unknown
BioHorizons	PGNHA5L	FDA UDI	Class II	Active
BioHorizons	NB-NPSA	FDA UDI	Class I	Unknown
BioHorizons	TMR5812	FDA UDI	Class II	Active
BioHorizons	235-217	FDA UDI	Class II	Unknown
BioHorizons	CGS-PGBIDHS	FDA UDI	Class I	Unknown
BioHorizons	BC2259.4330	FDA UDI	Class II	Active
BioHorizons	PXMUHAR	FDA UDI	Class I	Active
BioHorizons	TRX5815	FDA UDI	Class II	Active
BioHorizons	SYDCN	FDA UDI	Class I	Active
BioHorizons	TSC2030HDSU	FDA UDI	Class I	Active
BioHorizons	244-331	FDA UDI	Class I	Active
BioHorizons	TSL5807	FDA UDI	Class II	Active
BioHorizons	PGNHA3	FDA UDI	Class II	Active
BioHorizons	CNIDRL	FDA UDI	Class I	Active
BioHorizons	TRYPYMU17	FDA UDI	Class I	Active
BioHorizons	CGS-PGIDHS	FDA UDI	Class I	Unknown
BioHorizons	MDL2011SZ	FDA UDI	Class II	Active
BioHorizons	243-321	EUDAMEDFDA UDI	Class I	Active
BioHorizons	CRTE2T	FDA UDI	Class II	Active
BioHorizons	TSGG75	FDA UDI	Class I	Active
BioHorizons	PYCC	FDA UDI	Class II	Active
BioHorizons	PYMU304	FDA UDI	Class II	Active
BioHorizons	MUCA	EUDAMEDFDA UDI	Class I	Active
BioHorizons	PADS14	FDA UDI	Class I	Active
BioHorizons	PBPCAN	FDA UDI	Class II	Unknown
BioHorizons	TLX3415	FDA UDI	Class II	Active
BioHorizons	CR15A1W	FDA UDI	Class II	Active
BioHorizons	AFS405-25	FDA UDI	Class II	Unknown
BioHorizons	LPBR50105	FDA UDI	Class II	Unknown
BioHorizons	MDLCADZ	FDA UDI	Class I	Active
BioHorizons	CGS-2817SU	FDA UDI	Class I	Active
BioHorizons	PGSSEA3	FDA UDI	Class II	Active
BioHorizons	NB-29475	FDA UDI	Class II	Unknown
BioHorizons	212-604	FDA UDI	Class II	Active
BioHorizons	ATKG1	FDA UDI	Class I	Active
BioHorizons	CTR3310	FDA UDI	Class II	Active
BioHorizons	PYHA08L	FDA UDI	Class II	Active
BioHorizons	PBTTH	FDA UDI	Class II	Active
BioHorizons	BTR4615	FDA UDI	Class II	Active
BioHorizons	PBCC	FDA UDI	Class II	Active
BioHorizons	PGTBWSI	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.