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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 7 of 37

Device	Model / Reference	Registries	Class	Status
BioHorizons	PGODSK0	FDA UDI	Class II	Active
BioHorizons	PYSCA3	FDA UDI	Class II	Active
BioHorizons	MDLORZ	FDA UDI	Class I	Active
BioHorizons	TP3MU2L	FDA UDI	Class II	Active
BioHorizons	PHA	FDA UDI	Class I	Active
BioHorizons	TST2046	FDA UDI	Class I	Active
BioHorizons	OD-IAHC	FDA UDI	Class I	Active
BioHorizons	SBIA	FDA UDI	Class I	Active
BioHorizons	PGHA28L	FDA UDI	Class II	Active
BioHorizons	PYSSHA1T	FDA UDI	Class II	Active
BioHorizons	CNSSHA2	FDA UDI	Class II	Active
BioHorizons	CRTRYl7	FDA UDI	Class I	Active
BioHorizons	SGPWSC	FDA UDI	Class I	Active
BioHorizons	PGRISC	FDA UDI	Class I	Active
BioHorizons	CRHA6EW	FDA UDI	Class II	Active
BioHorizons	NB-NPTBL	FDA UDI	Class II	Unknown
BioHorizons	263-004	FDA UDI	Class II	Unknown
BioHorizons	TRX3410	FDA UDI	Class II	Active
BioHorizons	PGMU303	FDA UDI	Class II	Active
BioHorizons	CBDRS	FDA UDI	Class I	Active
BioHorizons	BTR4209	FDA UDI	Class II	Active
BioHorizons	CTR4210	FDA UDI	Class II	Active
BioHorizons	PTG4218	FDA UDI	Class II	Active
BioHorizons	PBWHA3	FDA UDI	Class II	Active
BioHorizons	PXMUAS25	FDA UDI	Class II	Active
BioHorizons	BCIY	FDA UDI	Class I	Active
BioHorizons	TIMD8007SU	FDA UDI	Class I	Active
BioHorizons	C2273.4330	FDA UDI	Class II	Active
BioHorizons	PB4018L	FDA UDI	Class II	Active
BioHorizons	BTR4212	FDA UDI	Class II	Active
BioHorizons	BTA5215	FDA UDI	Class II	Active
BioHorizons	PYBA3	FDA UDI	Class II	Active
BioHorizons	TIMD7009SU	FDA UDI	Class I	Active
BioHorizons	C2273.4310	FDA UDI	Class II	Active
BioHorizons	PYSEA3	FDA UDI	Class II	Active
BioHorizons	NB-WPTBL	FDA UDI	Class II	Unknown
BioHorizons	C2273.5020	FDA UDI	Class II	Active
BioHorizons	122-403	FDA UDI	Class I	Unknown
BioHorizons	OD-GY-4	FDA UDI	Class II	Active
BioHorizons	BC2258.4330	FDA UDI	Class II	Active
BioHorizons	TSC2038HDSU	FDA UDI	Class I	Active
BioHorizons	MDL2513SZ	FDA UDI	Class II	Active
BioHorizons	PCBD40	FDA UDI	Class I	Unknown
BioHorizons	SYCD35	FDA UDI	Class I	Unknown
BioHorizons	PYMU305	FDA UDI	Class II	Active
BioHorizons	TSGKIT	FDA UDI	Class I	Active
BioHorizons	TP3TB	FDA UDI	Class II	Active
BioHorizons	PYPTC	FDA UDI	Class II	Active
BioHorizons	SYHA30	FDA UDI	Class II	Active
BioHorizons	TMR3815	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.