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Sign in to claim this brandBIOHORIZONS 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/
- —
- —
- [email protected]
- Phone
- +1 (205) 968-7994
- PRRC Contact
- Jared Cooper
- EUDAMED SRN
- US-MF-000014002
- FDA FEI Number
- 1000592496
- DUNS Number
- —
Catalogue (1838)
Page 1 of 37| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BioHorizons | PROID30 | EUDAMED | Class I | Active |
| BioHorizons | CGS-5417SU | FDA UDI | Class I | Active |
| BioHorizons | PBDBP | FDA UDI | Class I | Active |
| BioHorizons | TSD2054HDSU | FDA UDI | Class I | Active |
| BioHorizons | PXABGC | FDA UDI | Class I | Active |
| BioHorizons | BCIG | FDA UDI | Class I | Active |
| BioHorizons | 212-404 | FDA UDI | Class II | Active |
| BioHorizons | BC2255.4320 | FDA UDI | Class II | Active |
| BioHorizons | SYHYBXD | FDA UDI | Class II | Active |
| BioHorizons | PHYBWSS | FDA UDI | Class I | Active |
| BioHorizons | MU-AR | FDA UDI | Class I | Active |
| BioHorizons | PGCMAW | FDA UDI | Class II | Active |
| BioHorizons | 206-611 | FDA UDI | Class II | Active |
| BioHorizons | CM-YW | FDA UDI | Class II | Active |
| BioHorizons | TDG2030 | FDA UDI | Class I | Active |
| BioHorizons | TP3IDRR | FDA UDI | Class I | Active |
| BioHorizons | CNTEA | FDA UDI | Class II | Active |
| BioHorizons | 122-242 | FDA UDI | Class I | Active |
| BioHorizons | MDL2018SZ | FDA UDI | Class II | Active |
| BioHorizons | CTA3309 | FDA UDI | Class II | Active |
| BioHorizons | SBR55 | FDA UDI | Class I | Active |
| BioHorizons | CTR3309 | FDA UDI | Class II | Active |
| BioHorizons | MLW3010Z | FDA UDI | Class II | Active |
| BioHorizons | PGODS4 | FDA UDI | Class II | Active |
| BioHorizons | 3DS4209 | FDA UDI | Class II | Active |
| BioHorizons | TIMD7010 | FDA UDI | Class I | Active |
| BioHorizons | PGCMAX | FDA UDI | Class II | Active |
| BioHorizons | 144-300 | FDA UDI | Class I | Active |
| BioHorizons | CTA3809 | FDA UDI | Class II | Active |
| BioHorizons | BC2256.3330 | FDA UDI | Class II | Active |
| BioHorizons | SGPIC55 | FDA UDI | Class I | Active |
| BioHorizons | PBSEAL | FDA UDI | Class II | Active |
| BioHorizons | TLR4615 | FDA UDI | Class II | Active |
| BioHorizons | 122-12509 | FDA UDI | Class I | Active |
| BioHorizons | TP3ODS1 | FDA UDI | Class II | Active |
| BioHorizons | GD-3217 | FDA UDI | Class I | Active |
| BioHorizons | PBBP | FDA UDI | Class I | Unknown |
| BioHorizons | LPGR40105 | FDA UDI | Class II | Unknown |
| BioHorizons | BTUBEHOLDZ | FDA UDI | Class II | Active |
| BioHorizons | 160-301 | FDA UDI | Class I | Unknown |
| BioHorizons | PBR6012 | FDA UDI | Class II | Unknown |
| BioHorizons | PGHYB2 | FDA UDI | Class II | Active |
| BioHorizons | PGRATA | FDA UDI | Class II | Active |
| BioHorizons | PGHYBN | FDA UDI | Class II | Active |
| BioHorizons | 205-511 | FDA UDI | Class II | Active |
| BioHorizons | 212-503 | FDA UDI | Class II | Active |
| BioHorizons | TP3CTA1L | FDA UDI | Class II | Unknown |
| BioHorizons | OD-GY-1 | FDA UDI | Class II | Active |
| BioHorizons | PYNHA5L | FDA UDI | Class II | Active |
| BioHorizons | 10032 | 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. |