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BIOHORIZONS IMPLANT SYSTEMS INC.

United States·US-MF-000014002

Last updated September 17, 2026

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 2 of 37

Device	Model / Reference	Registries	Class	Status
BioHorizons	PGODSK5	FDA UDI	Class II	Active
BioHorizons	NB-WPTBLS	FDA UDI	Class I	Unknown
BioHorizons	PYHA28L	FDA UDI	Class II	Active
BioHorizons	PXABCC	FDA UDI	Class II	Active
BioHorizons	TP3SAEA	FDA UDI	Class II	Active
BioHorizons	PYODS0	FDA UDI	Class II	Active
BioHorizons	CRHA6W	FDA UDI	Class II	Active
BioHorizons	CGS-5428SU	FDA UDI	Class I	Active
BioHorizons	PBCMA	FDA UDI	Class II	Active
BioHorizons	SGRP55	FDA UDI	Class I	Active
BioHorizons	PBDPCA	FDA UDI	Class II	Active
BioHorizons	IL-3312	FDA UDI	Class II	Active
BioHorizons	PBRCA	FDA UDI	Class II	Active
BioHorizons	HA-GY-R3	FDA UDI	Class II	Active
BioHorizons	LPYR3515	FDA UDI	Class II	Unknown
BioHorizons	CRSSHM2	FDA UDI	Class II	Active
BioHorizons	214-235	FDA UDI	Class I	Active
BioHorizons	CLS	FDA UDI	Class I	Active
BioHorizons	PROTPYL	FDA UDI	Class I	Active
BioHorizons	CRSSHM1	FDA UDI	Class II	Active
BioHorizons	PROLD3706	FDA UDI	Class I	Active
BioHorizons	SBRP40	FDA UDI	Class I	Active
BioHorizons	212-606	FDA UDI	Class II	Unknown
BioHorizons	MLTZ	FDA UDI	Class I	Active
BioHorizons	TP3SEA3L	FDA UDI	Class II	Active
BioHorizons	CTA5210	FDA UDI	Class II	Active
BioHorizons	PGMU1	FDA UDI	Class II	Active
BioHorizons	TRX5807	FDA UDI	Class II	Active
BioHorizons	NB-33451	FDA UDI	Class II	Unknown
BioHorizons	SGPIC40	FDA UDI	Class I	Active
BioHorizons	CMUAS25	FDA UDI	Class II	Active
BioHorizons	PYSSHM2T	FDA UDI	Class II	Active
BioHorizons	TIMD7009	FDA UDI	Class I	Active
BioHorizons	BTA4615	FDA UDI	Class II	Active
BioHorizons	SGCAN	FDA UDI	Class II	Active
BioHorizons	PYRCA	FDA UDI	Class II	Active
BioHorizons	CGS-3721SU	FDA UDI	Class I	Active
BioHorizons	PBETNL	FDA UDI	Class II	Active
BioHorizons	PYSSHA2T	FDA UDI	Class II	Active
BioHorizons	5605	FDA UDI	Class I	Active
BioHorizons	SYAP55	FDA UDI	Class II	Active
BioHorizons	PBMU304	FDA UDI	Class II	Active
BioHorizons	CRMUS2N	FDA UDI	Class II	Active
BioHorizons	TRYTIM8007	FDA UDI	Class I	Active
BioHorizons	PGMU4L	FDA UDI	Class II	Active
BioHorizons	PBODSK0	FDA UDI	Class II	Active
BioHorizons	D1515Z	FDA UDI	Class I	Active
BioHorizons	BCAA	FDA UDI	Class I	Active
BioHorizons	MU-YW-S1	FDA UDI	Class II	Active
BioHorizons	TP3MU3L	FDA UDI	Class II	Active

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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.

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.