BioHorizons Implant Systems Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 40
- Inspections
- 7
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0391-2016 | Class II | RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHOR | October 30, 2015 |
| Z-1605-2015 | Class II | Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical inst | April 16, 2015 |
| Z-1058-2014 | Class II | External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), | December 10, 2013 |
| Z-0561-2013 | Class II | AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. D | November 19, 2012 |
| Z-0562-2013 | Class II | Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. | November 19, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243521 | Conical Ti Base abutments | May 1, 2025 |
| K240531 | SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment | July 30, 2024 |
| K240187 | Tapered Pro Conical Implant System | June 5, 2024 |
| K223697 | MRI compatibility for existing BioHorizons dental implants and abutments | October 13, 2023 |
| K203252 | Multi-unit Abutments for CONELOG | March 16, 2021 |
| K182070 | BioHorizons Tapered IM Implants | October 10, 2018 |
| K180998 | BioHorizons CAD/CAM Bars | September 28, 2018 |
| K172576 | BioHorizons Tapered Short Implants | November 22, 2017 |
| K151621 | BioHorizons CAD/CAM Abutments | January 13, 2016 |
| K143022 | BioHorizons Tapered Internal Implants | January 8, 2015 |
| K121787 | BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS | September 5, 2012 |
| K103291 | BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE | November 4, 2011 |
| K103691 | BIOHORIZONS ABUTMENTS FOR ZIMMER | November 3, 2011 |
| K100985 | BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK | September 9, 2010 |
| K093321 | BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM | April 2, 2010 |
| K081818 | BIOLOK MICRO-LOK IMPLANT SYSTEM | November 13, 2008 |
| K073282 | BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM | February 15, 2008 |
| K073268 | BIOHORIZONS INTERNAL IMPLANT SYSTEM | February 8, 2008 |
| K071638 | BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM | October 10, 2007 |
| K061567 | BIOHORIZONS CERAMIC ABUTMENT | November 22, 2006 |