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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 4 of 37

Device	Model / Reference	Registries	Class	Status
BioHorizons	TP3AH	FDA UDI	Class I	Active
BioHorizons	PGSAEA	FDA UDI	Class II	Active
BioHorizons	TLR4612	FDA UDI	Class II	Active
BioHorizons	TTLG4607	FDA UDI	Class II	Active
BioHorizons	TD-2512	FDA UDI	Class I	Active
BioHorizons	IL-3315	FDA UDI	Class II	Active
BioHorizons	BTA5209	FDA UDI	Class II	Active
BioHorizons	264-002	FDA UDI	Class II	Unknown
BioHorizons	TLXP3815	FDA UDI	Class II	Active
BioHorizons	TP3TBL	FDA UDI	Class II	Active
BioHorizons	TTLG4609	FDA UDI	Class II	Active
BioHorizons	PROLD5415	FDA UDI	Class I	Active
BioHorizons	CRIC	FDA UDI	Class I	Active
BioHorizons	TB-YW-N	FDA UDI	Class II	Active
BioHorizons	BC2257.3330	FDA UDI	Class II	Active
BioHorizons	CN30MU3	FDA UDI	Class II	Active
BioHorizons	CTRZ	FDA UDI	Class I	Active
BioHorizons	SYGIDH	FDA UDI	Class I	Unknown
BioHorizons	BP-GY	FDA UDI	Class I	Active
BioHorizons	BTR4215	FDA UDI	Class II	Active
BioHorizons	MDL2010SZ	FDA UDI	Class II	Active
BioHorizons	SBHA20	FDA UDI	Class II	Active
BioHorizons	PGH4009	FDA UDI	Class II	Unknown
BioHorizons	IL-5007	FDA UDI	Class II	Active
BioHorizons	LPGR4009	FDA UDI	Class II	Unknown
BioHorizons	PYCMAW	FDA UDI	Class II	Active
BioHorizons	IL-PT	FDA UDI	Class I	Active
BioHorizons	TSGG60	FDA UDI	Class I	Active
BioHorizons	CRTEA	FDA UDI	Class II	Active
BioHorizons	IL-GK	FDA UDI	Class I	Active
BioHorizons	BFUSE110Z	FDA UDI	Class II	Active
BioHorizons	MLW3011Z	FDA UDI	Class II	Active
BioHorizons	TRXP3809	FDA UDI	Class II	Active
BioHorizons	330-200OS	FDA UDI	Class I	Unknown
BioHorizons	212-406	FDA UDI	Class II	Unknown
BioHorizons	PBSREA	FDA UDI	Class II	Active
BioHorizons	TP3CAH	FDA UDI	Class II	Active
BioHorizons	OD-IAPI	FDA UDI	Class I	Active
BioHorizons	PBODS6	FDA UDI	Class II	Active
BioHorizons	PGBPA	FDA UDI	Class II	Active
BioHorizons	PROLD5412	FDA UDI	Class I	Active
Biohorizons	MDLMMHSZ	FDA UDI	Class I	Active
BioHorizons	LPRF220	FDA UDI	Class II	Active
BioHorizons	PGRHA5L	FDA UDI	Class II	Active
BioHorizons	TD-2509	FDA UDI	Class I	Active
BioHorizons	PT35	FDA UDI	Class I	Unknown
BioHorizons	TP3MU303	FDA UDI	Class II	Active
BioHorizons	263-006	FDA UDI	Class II	Unknown
BioHorizons	TP3ETPS	FDA UDI	Class I	Active
BioHorizons	PYNHA1	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.