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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 19 of 37

Device	Model / Reference	Registries	Class	Status
BioHorizons	TTLY3809	FDA UDI	Class II	Active
BioHorizons	PYGAH	FDA UDI	Class I	Active
BioHorizons	CC-YW-PN	FDA UDI	Class II	Unknown
BioHorizons	122-202	FDA UDI	Class I	Unknown
BioHorizons	TIMD8009	FDA UDI	Class I	Active
BioHorizons	NB-33449	FDA UDI	Class II	Unknown
BioHorizons	SBDCN	FDA UDI	Class I	Active
BioHorizons	TLX4612	FDA UDI	Class II	Active
BioHorizons	PYH35105	FDA UDI	Class II	Unknown
BioHorizons	204-504	FDA UDI	Class II	Unknown
BioHorizons	TP3WHA5	FDA UDI	Class II	Active
BioHorizons	CGS-DGB20	FDA UDI	Class I	Active
BioHorizons	MU-DC	FDA UDI	Class I	Active
BioHorizons	CRSA3	FDA UDI	Class II	Active
BioHorizons	CGS-4724	FDA UDI	Class I	Active
BioHorizons	140-400	FDA UDI	Class II	Unknown
BioHorizons	PYR3515	FDA UDI	Class II	Unknown
BioHorizons	GD-2828	FDA UDI	Class I	Active
BioHorizons	CTA3810R	FDA UDI	Class II	Active
BioHorizons	PGODS3	FDA UDI	Class II	Active
BioHorizons	TSD2028DB	FDA UDI	Class I	Active
BioHorizons	CRSA3W	FDA UDI	Class II	Active
BioHorizons	CRTE0T	FDA UDI	Class II	Active
BioHorizons	CM-GY	FDA UDI	Class II	Active
BioHorizons	BTA3809	FDA UDI	Class II	Active
BioHorizons	TRXP5812	FDA UDI	Class II	Active
BioHorizons	CN30MU2	FDA UDI	Class II	Active
BioHorizons	212-304	FDA UDI	Class II	Active
BioHorizons	2621	FDA UDI	Class I	Active
BioHorizons	400-248	FDA UDI	Class I	Active
BioHorizons	TP3IDH	FDA UDI	Class I	Active
BioHorizons	SBCD60	FDA UDI	Class I	Unknown
BioHorizons	PGRCA	FDA UDI	Class II	Active
BioHorizons	PYAFS5	FDA UDI	Class II	Active
BioHorizons	PGSSHM2	FDA UDI	Class II	Active
BioHorizons	CTA3810	FDA UDI	Class II	Active
BioHorizons	235-227	FDA UDI	Class II	Active
BioHorizons	TMR5815	FDA UDI	Class II	Active
BioHorizons	PB4028L	FDA UDI	Class II	Active
BioHorizons	155-000	FDA UDI	Class I	Unknown
BioHorizons	PHYBWSL	FDA UDI	Class I	Active
BioHorizons	TP3MU3	FDA UDI	Class II	Active
BioHorizons	TLXP5810	FDA UDI	Class II	Active
BioHorizons	MU-IC	FDA UDI	Class I	Active
BioHorizons	OD-CM	FDA UDI	Class I	Active
BioHorizons	PYSSHP2	FDA UDI	Class II	Active
BioHorizons	PBPTC	FDA UDI	Class II	Active
BioHorizons	PYCAH	FDA UDI	Class II	Active
BioHorizons	CRTRY30	FDA UDI	Class I	Active
BioHorizons	ODSCIT	FDA UDI	Class I	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.