Company · US
BioHorizons Implant Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2026. Name variants (Inc, Corp, punctuation) are merged.
41510(k) clearances (1 in 12 months)
14recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 26, 2026 | K260061 | BioHorizons CEREC Compatible Ti-Bases BioHorizons Implant Systems, Inc. | NHA |
| May 1, 2025 | K243521 | Conical Ti Base abutments BioHorizons Implant Systems, Inc. | NHA |
| Jul 30, 2024 | K240531 | SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment BioHorizons Implant Systems, Inc. | NHA |
| Jun 5, 2024 | K240187 | Tapered Pro Conical Implant System BioHorizons Implant Systems, Inc. | DZE |
| Oct 13, 2023 | K223697 | MRI compatibility for existing BioHorizons dental implants and abutments BioHorizons Implant Systems, Inc. | DZE |
| Mar 16, 2021 | K203252 | Multi-unit Abutments for CONELOG BioHorizons Implant Systems, Inc. | NHA |
| Oct 10, 2018 | K182070 | BioHorizons Tapered IM Implants BioHorizons Implant Systems, Inc. | DZE |
| Sep 28, 2018 | K180998 | BioHorizons CAD/CAM Bars BioHorizons Implant Systems, Inc. | NHA |
| Nov 22, 2017 | K172576 | BioHorizons Tapered Short Implants BioHorizons Implant Systems, Inc. | DZE |
| Jan 13, 2016 | K151621 | BioHorizons CAD/CAM Abutments BioHorizons Implant Systems, Inc. | NHA |
| Jan 8, 2015 | K143022 | BioHorizons Tapered Internal Implants BioHorizons Implant Systems, Inc. | DZE |
| Sep 5, 2012 | K121787 | BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS BioHorizons Implant Systems, Inc. | DZE |
| Nov 4, 2011 | K103291 | BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE BioHorizons Implant Systems, Inc. | NHA |
| Nov 3, 2011 | K103691 | BIOHORIZONS ABUTMENTS FOR ZIMMER BioHorizons Implant Systems, Inc. | NHA |
| Sep 9, 2010 | K100985 | BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK BioHorizons Implant Systems, Inc. | NHA |
| Apr 2, 2010 | K093321 | BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM BioHorizons Implant Systems, Inc. | DZE |
| Nov 13, 2008 | K081818 | BIOLOK MICRO-LOK IMPLANT SYSTEM BioHorizons Implant Systems, Inc. | DZE |
| Feb 15, 2008 | K073282 | BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM BioHorizons Implant Systems, Inc. | DZE |
| Feb 8, 2008 | K073268 | BIOHORIZONS INTERNAL IMPLANT SYSTEM BioHorizons Implant Systems, Inc. | DZE |
| Oct 10, 2007 | K071638 | BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM BioHorizons Implant Systems, Inc. | DZE |
| Nov 22, 2006 | K061567 | BIOHORIZONS CERAMIC ABUTMENT BioHorizons Implant Systems, Inc. | NHA |
| Feb 14, 2006 | K053099 | BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS BioHorizons Implant Systems, Inc. | NHA |
| Dec 2, 2005 | K053152 | BIOHORIZONS SINGLE-STAGE IMPLANT BioHorizons Implant Systems, Inc. | DZE |
| Sep 20, 2005 | K052419 | MAXIMUS 3.0 AND OS IMPLANTS BioHorizons Implant Systems, Inc. | DZE |
| Sep 16, 2004 | K042429 | THE PRODIGY SYSTEM DENTAL IMPLANTS BioHorizons Implant Systems, Inc. | DZE |
| Jul 22, 2004 | K041938 | MAXIMUS OS (OVERDENTURE SYSTEM) BioHorizons Implant Systems, Inc. | DZE |
| Oct 21, 2003 | K032351 | THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT BioHorizons Implant Systems, Inc. | DZE |
| Feb 26, 2003 | K030463 | MODIFICATION TO THE MAESTRO SYSTEM BioHorizons Implant Systems, Inc. | DZE |
| Aug 30, 2002 | K022795 | MODIFICATION TO THE MAESTRO SYSTEM BioHorizons Implant Systems, Inc. | NHA |
| Aug 28, 2002 | K022790 | THE AUTOTAC SYSTEM TITANIUM TACK BioHorizons Implant Systems, Inc. | DZL |
| Mar 15, 2002 | K020645 | MODIFICATION TO THE MAESTRO SYSTEM BioHorizons Implant Systems, Inc. | DZE |
| Jan 25, 2002 | K020133 | MODIFICATION TO THE MAESTRO SYSTEM BioHorizons Implant Systems, Inc. | DZE |
| Jun 22, 2001 | K011675 | THE AUTOTAC SYSTEM BioHorizons Implant Systems, Inc. | DZL |
| May 10, 2001 | K010458 | THE MAESTRO SYSTEM BioHorizons Implant Systems, Inc. | DZE |
| Jan 7, 2000 | K993493 | THE AUTOTAC SYSTEM BioHorizons Implant Systems, Inc. | DZL |
| Apr 9, 1999 | K990277 | O-RING ABUTMENT BioHorizons Implant Systems, Inc. | DZE |
| Mar 4, 1998 | K980374 | IMPLANT SITE DILATORS BioHorizons Implant Systems, Inc. | DZE |
| Sep 16, 1997 | K972313 | THE MAESTRO SYSTEM BioHorizons Implant Systems, Inc. | DZE |
| Jan 17, 1997 | K964330 | BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE) BioHorizons Implant Systems, Inc. | DZE |
| Dec 31, 1996 | K963951 | AS 123 PROSTHETIC INSTRUMENTATION SYSTEM BioHorizons Implant Systems, Inc. | DZE |
| Mar 28, 1996 | K960026 | BIOHORIZONS DENTAL IMPLANT SYSTEM BioHorizons Implant Systems, Inc. | DZE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 7, 2015 | BioHorizons Implant Systems Inc RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R),
Dental Implant Terminated |
DZE | K073268 |
| May 12, 2015 | BioHorizons Implant Systems Inc Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only,
Product Usage Usage:
Surgical instruments used in preparation for dental implant placement Terminated |
DZE | K071638 |
| Feb 20, 2014 | BioHorizons Implant Systems Inc External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244
Usage: dental Terminated |
DZE | K030463 |
| Dec 19, 2012 | BioHorizons Implant Systems Inc Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244.
Dental. Terminated |
DZE | None listed |
| Dec 19, 2012 | BioHorizons Implant Systems Inc AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244.
Dental. Terminated |
DZE | K993493 |
| Nov 4, 2010 | BioHorizons Implant Systems Inc Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE R, gamma irradiated, expires 2014-44, CE 0473, BIOHORIZONS, BIRMINGHAM, AL 35244.
Endosseous dental implant healing abutment. Terminated |
DZE | K053152 |
| May 11, 2007 | BioHorizons Implant Systems Inc Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243 Terminated |
DZE | K041938 |
| Apr 13, 2007 | BioHorizons Implant Systems Inc BioHorizons 0.050 Hex Driver, Regular, REF 134-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only. The product is part of a Prosthetic Instrumentation system Kit 51-K Terminated |
DZE | None listed |
| Apr 13, 2007 | BioHorizons Implant Systems Inc BioHorizons 0.050 Hex Driver, Long, REF 300-351, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only Terminated |
DZE | K963951 |
| Apr 13, 2007 | BioHorizons Implant Systems Inc BioHorizons 0.050 Hex Driver, Regular, REF 300-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only Terminated |
DZE | K963951 |
| Apr 13, 2007 | BioHorizons Implant Systems Inc BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only, REF 300-377. Terminated |
DZE | K963951 |
| Dec 6, 2006 | BioHorizons Implant Systems Inc BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit Terminated |
DZE | K041938 |
| Jun 23, 2005 | BioHorizons Implant Systems Inc The Maestor System 225-312, Profile Abutment for Cement, 5mm Terminated |
NDP | None listed |
| Jun 23, 2005 | BioHorizons Implant Systems Inc The Maestro System 204-503, Straight Permucosal Ext, 5mm x 3mm Terminated |
NDP | None listed |