BioHorizons Implant Systems Inc
FDA Regulatory Profile
BioHorizons Implant Systems Inc has 5 FDA recalls, 7 inspections, 41 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-0391-2016 · Class II · Oct 30, 2015
- Latest inspection
- Feb 27, 2025 · NAI
- Latest 510(k)
- Jun 26, 2026
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 5 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 41 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 7 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
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… | Oct 30, 2015 |
| Z-1605-2015 | Class II | Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical… | Apr 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)… | Dec 10, 2013 |
| Z-0561-2013 | Class II | AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244… | Nov 19, 2012 |
| Z-0562-2013 | Class II | Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244… | Nov 19, 2012 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Feb 27, 2025 | Hoover, AL | Biologics | No Action Indicated (NAI) | 1000592496 |
| Mar 5, 2019 | Hoover, AL | Biologics | No Action Indicated (NAI) | 1000592496 |
| Jan 29, 2016 | Hoover, AL | Devices | No Action Indicated (NAI) | 1000592496 |
| Jan 28, 2016 | Hoover, AL | Biologics | No Action Indicated (NAI) | 1000592496 |
| May 30, 2013 | Hoover, AL | Devices | No Action Indicated (NAI) | 1000592496 |
| Apr 29, 2013 | Hoover, AL | Biologics | No Action Indicated (NAI) | 1000592496 |
| Nov 10, 2010 | Hoover, AL | Devices | No Action Indicated (NAI) | 1000592496 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 1000592496 | Hoover, AL | 7 | Feb 27, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260061 | BioHorizons CEREC Compatible Ti-Bases | Jun 26, 2026 |
| K243521 | Conical Ti Base abutments | May 1, 2025 |
| K240531 | SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment | Jul 30, 2024 |
| K240187 | Tapered Pro Conical Implant System | Jun 5, 2024 |
| K223697 | MRI compatibility for existing BioHorizons dental implants and abutments | Oct 13, 2023 |
| K203252 | Multi-unit Abutments for CONELOG | Mar 16, 2021 |
| K182070 | BioHorizons Tapered IM Implants | Oct 10, 2018 |
| K180998 | BioHorizons CAD/CAM Bars | Sep 28, 2018 |
| K172576 | BioHorizons Tapered Short Implants | Nov 22, 2017 |
| K151621 | BioHorizons CAD/CAM Abutments | Jan 13, 2016 |
| K143022 | BioHorizons Tapered Internal Implants | Jan 8, 2015 |
| K121787 | BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS | Sep 5, 2012 |
| K103291 | BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE | Nov 4, 2011 |
| K103691 | BIOHORIZONS ABUTMENTS FOR ZIMMER | Nov 3, 2011 |
| K100985 | BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK | Sep 9, 2010 |
| K093321 | BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM | Apr 2, 2010 |
| K081818 | BIOLOK MICRO-LOK IMPLANT SYSTEM | Nov 13, 2008 |
| K073282 | BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM | Feb 15, 2008 |
| K073268 | BIOHORIZONS INTERNAL IMPLANT SYSTEM | Feb 8, 2008 |
| K071638 | BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM | Oct 10, 2007 |