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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 5 of 37

Device	Model / Reference	Registries	Class	Status
BioHorizons	NB-35804	FDA UDI	Class II	Unknown
BioHorizons	244-320	FDA UDI	Class I	Active
BioHorizons	PXDCSL	FDA UDI	Class I	Active
BioHorizons	TIM8009	FDA UDI	Class II	Active
BioHorizons	NB-WPSA	FDA UDI	Class I	Unknown
BioHorizons	PBHYBN	FDA UDI	Class II	Active
BioHorizons	MU-GY-172	FDA UDI	Class II	Active
BioHorizons	TSD2041	FDA UDI	Class I	Unknown
BioHorizons	SYHA20	FDA UDI	Class II	Active
BioHorizons	PYNHA5	FDA UDI	Class II	Active
BioHorizons	MDLSAPZ	FDA UDI	Class II	Active
BioHorizons	BTA4618	FDA UDI	Class II	Active
BioHorizons	CGS3500	FDA UDI	Class I	Active
BioHorizons	122-230	FDA UDI	Class I	Active
BioHorizons	TRX3810	FDA UDI	Class II	Active
BioHorizons	243-320	FDA UDI	Class I	Active
BioHorizons	TIMD7010SU	FDA UDI	Class I	Active
BioHorizons	300-351	FDA UDI	Class I	Active
BioHorizons	CRTN0	FDA UDI	Class II	Active
BioHorizons	SYPWSB	FDA UDI	Class I	Active
BioHorizons	SBRP55	FDA UDI	Class I	Active
BioHorizons	PXMUHAM	FDA UDI	Class I	Active
BioHorizons	TSK4000	FDA UDI	Class I	Active
BioHorizons	TMR3810	FDA UDI	Class II	Active
BioHorizons	TP3DCN	FDA UDI	Class I	Active
BioHorizons	TSL5806	FDA UDI	Class II	Active
BioHorizons	CGS-4128	FDA UDI	Class I	Active
BioHorizons	265-006	FDA UDI	Class II	Unknown
BioHorizons	TP3NHA5	FDA UDI	Class II	Active
BioHorizons	NB-29446	FDA UDI	Class II	Unknown
BioHorizons	PGH40105	FDA UDI	Class II	Unknown
BioHorizons	OD-A	FDA UDI	Class I	Active
BioHorizons	PGSSHP1T	FDA UDI	Class II	Active
BioHorizons	TSC2030HD	FDA UDI	Class I	Active
BioHorizons	CN30MU4	FDA UDI	Class II	Active
BioHorizons	BC2255.43TRY	FDA UDI	Class I	Active
BioHorizons	CRHA2	FDA UDI	Class II	Active
BioHorizons	CS-GY	FDA UDI	Class II	Active
BioHorizons	PBRAA	FDA UDI	Class II	Active
BioHorizons	PGODS1	FDA UDI	Class II	Active
BioHorizons	BTD3712	FDA UDI	Class I	Unknown
BioHorizons	PGMUBP	FDA UDI	Class I	Active
BioHorizons	TLX3010	FDA UDI	Class II	Active
BioHorizons	BCAHT	FDA UDI	Class I	Active
BioHorizons	IL-5009	FDA UDI	Class II	Active
BioHorizons	PXETPS	EUDAMEDFDA UDI	Class I	Active
BioHorizons	TP3CBD	FDA UDI	Class I	Unknown
BioHorizons	CRICC	FDA UDI	Class I	Active
BioHorizons	BSDRHL	FDA UDI	Class I	Unknown
BioHorizons	PYODS4	FDA UDI	Class II	Active

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Authorities

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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.