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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 22 of 37

Device	Model / Reference	Registries	Class	Status
BioHorizons	130-000	FDA UDI	Class I	Active
BioHorizons	OD-GY-2	FDA UDI	Class II	Active
BioHorizons	TLR3815	FDA UDI	Class II	Active
BioHorizons	MU-GY-173	FDA UDI	Class II	Active
BioHorizons	BC2256.4320	FDA UDI	Class II	Active
BioHorizons	TSD2054DB	FDA UDI	Class I	Active
BioHorizons	TP3IDRL	FDA UDI	Class I	Active
BioHorizons	TOD2041	FDA UDI	Class I	Active
BioHorizons	TP3ODS5	FDA UDI	Class II	Active
BioHorizons	PBNHA2	FDA UDI	Class II	Active
BioHorizons	TSC2034HDSU	FDA UDI	Class I	Active
BioHorizons	LPGR4012	FDA UDI	Class II	Unknown
BioHorizons	ATKG3	FDA UDI	Class I	Active
BioHorizons	135-351	FDA UDI	Class I	Active
BioHorizons	TP3ST	FDA UDI	Class I	Unknown
BioHorizons	4009D3	FDA UDI	Class II	Unknown
BioHorizons	CNHA4W	FDA UDI	Class II	Active
BioHorizons	LPYR35105	FDA UDI	Class II	Unknown
BioHorizons	234-214	FDA UDI	Class II	Active
BioHorizons	212-603	FDA UDI	Class II	Active
BioHorizons	MDL2013Z	FDA UDI	Class II	Active
BioHorizons	PBHYB	FDA UDI	Class II	Active
BioHorizons	5023/2905	FDA UDI	Class II	Unknown
BioHorizons	TSK2500	FDA UDI	Class I	Unknown
BioHorizons	CNCC	FDA UDI	Class II	Active
BioHorizons	MDL2510Z	FDA UDI	Class II	Active
BioHorizons	MDL2011Z	FDA UDI	Class II	Active
BioHorizons	TRXP4609	FDA UDI	Class II	Active
BioHorizons	CTA3812R	FDA UDI	Class II	Active
BioHorizons	CRTRYS	FDA UDI	Class I	Active
BioHorizons	BC2255.3340	FDA UDI	Class II	Active
BioHorizons	TP3CAN	FDA UDI	Class II	Active
BioHorizons	C2273.3340	FDA UDI	Class II	Active
BioHorizons	PYBP	FDA UDI	Class I	Unknown
BioHorizons	TP3IDR	FDA UDI	Class I	Unknown
BioHorizons	PROLD4106	FDA UDI	Class I	Active
BioHorizons	MDL-ST	FDA UDI	Class I	Active
BioHorizons	PYODS5	FDA UDI	Class II	Active
BioHorizons	203-311	FDA UDI	Class II	Active
BioHorizons	3DS4215	FDA UDI	Class II	Active
BioHorizons	2907	FDA UDI	Class II	Active
BioHorizons	233-214	FDA UDI	Class II	Active
BioHorizons	CTA5207	FDA UDI	Class II	Active
BioHorizons	IL-4215	FDA UDI	Class II	Active
BioHorizons	CTR4215	FDA UDI	Class II	Active
BioHorizons	MLAZ	FDA UDI	Class I	Active
BioHorizons	PBR50105	FDA UDI	Class II	Unknown
BioHorizons	PBCAN	FDA UDI	Class II	Active
BioHorizons	TRYTIM8009	FDA UDI	Class I	Active
BioHorizons	TP3TTN	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.