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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 29 of 37

Device	Model / Reference	Registries	Class	Status
BioHorizons	CR20A3	FDA UDI	Class II	Active
BioHorizons	CNICWO	FDA UDI	Class I	Active
BioHorizons	BCMUCA	FDA UDI	Class I	Active
BioHorizons	TSD2054	FDA UDI	Class I	Unknown
BioHorizons	SYAP40	FDA UDI	Class II	Active
BioHorizons	PYMU174	FDA UDI	Class II	Active
BioHorizons	PYAEA	FDA UDI	Class II	Active
BioHorizons	124-000	FDA UDI	Class I	Unknown
BioHorizons	PYODSK4	FDA UDI	Class II	Active
BioHorizons	TIMD8010	FDA UDI	Class I	Active
BioHorizons	CC-YW-PH	FDA UDI	Class II	Unknown
BioHorizons	TP3BPAL	FDA UDI	Class II	Active
BioHorizons	IL-3812	FDA UDI	Class II	Active
BioHorizons	LPBR5012	FDA UDI	Class II	Unknown
BioHorizons	234-227	FDA UDI	Class II	Active
BioHorizons	TP3ODS0	FDA UDI	Class II	Active
BioHorizons	6015D3	FDA UDI	Class II	Unknown
BioHorizons	223-314	FDA UDI	Class II	Unknown
BioHorizons	CTR5210	FDA UDI	Class II	Active
BioHorizons	CBDHL	FDA UDI	Class I	Active
BioHorizons	CNSSHM1T	FDA UDI	Class II	Active
BioHorizons	CC-GY-N	FDA UDI	Class II	Active
BioHorizons	SYHA40	FDA UDI	Class II	Active
BioHorizons	4012D3	FDA UDI	Class II	Unknown
BioHorizons	TRYTP3MU	FDA UDI	Class I	Active
BioHorizons	CA-YW-A	FDA UDI	Class II	Active
BioHorizons	MDL2511Z	FDA UDI	Class II	Active
BioHorizons	TLR3810	FDA UDI	Class II	Active
BioHorizons	3507D3	FDA UDI	Class II	Unknown
BioHorizons	CTR3815R	FDA UDI	Class II	Active
BioHorizons	ODSRC-C	FDA UDI	Class I	Active
BioHorizons	50821/2907	FDA UDI	Class II	Active
BioHorizons	PYIA25	FDA UDI	Class I	Active
BioHorizons	TTLB5812	FDA UDI	Class II	Active
BioHorizons	PYBPGP	FDA UDI	Class I	Active
BioHorizons	PBMU2	FDA UDI	Class II	Active
BioHorizons	BTR5210	FDA UDI	Class II	Active
BioHorizons	PBBPAL	FDA UDI	Class II	Active
BioHorizons	MU-GY-S2	FDA UDI	Class II	Active
BioHorizons	CTA4609	FDA UDI	Class II	Active
BioHorizons	122-52018	FDA UDI	Class I	Unknown
BioHorizons	CNSSHA1	FDA UDI	Class II	Active
BioHorizons	IC-S	FDA UDI	Class I	Active
BioHorizons	PXMUDC	FDA UDI	Class I	Unknown
BioHorizons	PBRHA3L	FDA UDI	Class II	Active
BioHorizons	CA-GY-S	FDA UDI	Class II	Active
BioHorizons	NB-BPARPL	FDA UDI	Class II	Unknown
BioHorizons	2620N	FDA UDI	Class I	Active
BioHorizons	PGMU3L	FDA UDI	Class II	Active
BioHorizons	204-404	FDA UDI	Class II	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.