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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 3 of 37

Device	Model / Reference	Registries	Class	Status
BioHorizons	122-12512	FDA UDI	Class I	Active
BioHorizons	TRYPBMU30	FDA UDI	Class I	Active
BioHorizons	CTA4210	FDA UDI	Class II	Active
BioHorizons	122-024SU	FDA UDI	Class I	Active
BioHorizons	PBODSK5	FDA UDI	Class II	Active
BioHorizons	TDS42DB	FDA UDI	Class I	Active
BioHorizons	TP3EWHA3	FDA UDI	Class II	Active
BioHorizons	SBR40	FDA UDI	Class I	Active
BioHorizons	MDL-SK	FDA UDI	Class I	Active
BioHorizons	TLXP3810	FDA UDI	Class II	Active
BioHorizons	CTR4615	FDA UDI	Class II	Active
BioHorizons	BTA3818	FDA UDI	Class II	Active
BioHorizons	PBSSHP1	FDA UDI	Class II	Active
BioHorizons	PBMU1	FDA UDI	Class II	Active
BioHorizons	BC2256.4340	FDA UDI	Class II	Active
BioHorizons	TIM7009	FDA UDI	Class II	Active
BioHorizons	PYTG	FDA UDI	Class I	Active
BioHorizons	400-240	FDA UDI	Class II	Active
BioHorizons	PYWDC	FDA UDI	Class I	Active
BioHorizons	PYODS6	FDA UDI	Class II	Active
BioHorizons	TP3HA5L	FDA UDI	Class II	Active
BioHorizons	126-300	FDA UDI	Class I	Unknown
BioHorizons	PGBPAL	FDA UDI	Class II	Active
BioHorizons	123-000	FDA UDI	Class I	Unknown
BioHorizons	PBR5015	FDA UDI	Class II	Unknown
BioHorizons	PGCTA3L	FDA UDI	Class II	Unknown
BioHorizons	CTA4207	FDA UDI	Class II	Active
BioHorizons	TLX4609	FDA UDI	Class II	Active
BioHorizons	CRSA1W	FDA UDI	Class II	Active
BioHorizons	TSGG2	FDA UDI	Class I	Active
BioHorizons	BC2257.43TRY	FDA UDI	Class I	Active
BioHorizons	TTLG4610	FDA UDI	Class II	Active
BioHorizons	PBSSHP1T	FDA UDI	Class II	Active
BioHorizons	LPBR6015	FDA UDI	Class II	Unknown
BioHorizons	CGS-3728SU	FDA UDI	Class I	Active
BioHorizons	PGBA1	FDA UDI	Class II	Active
BioHorizons	IL-4210	FDA UDI	Class II	Active
BioHorizons	122-52012	FDA UDI	Class I	Unknown
BioHorizons	PGODS6	FDA UDI	Class II	Active
BioHorizons	SGHA40	FDA UDI	Class II	Active
BioHorizons	204-503	FDA UDI	Class II	Unknown
BioHorizons	BC2259.3330	FDA UDI	Class II	Active
BioHorizons	PYNDCN	FDA UDI	Class I	Active
BioHorizons	ODSCM	FDA UDI	Class I	Active
BioHorizons	BTA3812	FDA UDI	Class II	Active
BioHorizons	SGR55	FDA UDI	Class I	Active
BioHorizons	TST2046HDSU	FDA UDI	Class I	Active
BioHorizons	1031/2907	FDA UDI	Class II	Active
BioHorizons	SGPWSB	FDA UDI	Class I	Active
BioHorizons	TDS54	FDA UDI	Class I	Unknown

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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.