Data / Medical devices / United States / Biohorizons Implant Systems Inc.
Biohorizons Implant Systems Inc.: FDA-registered device maker in Birmingham, AL, United States, 42 510(k) clearances
Biohorizons Implant Systems Inc. is registered with the FDA (registration 1060818) in Birmingham, AL, United States. It lists 8 device types. The FDA files 42 510(k) clearances under its listings, the newest dated June 26, 2026. 9 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1060818
- FEI number
- 1000592496
- Address
- 2300 Riverchase Center, Birmingham, AL, United States, 35244
- Owner or operator
- BIOHORIZONS IMPLANT SYSTEMS, INC. (9024113)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- February 8, 1996
- Registered through
- 2026
- Brand names listed
- ACE BONE SCREW TACKING KIT, ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, BIOHORIZONS COMFORT CAP, BIOHORIZONS DENTAL IMPLANT ACCESSORIES, BioHorizons Abutments for Zimmer, BioHorizons CAD/CAM Abutments, BioHorizons Dental Implant System, BioHorizons Internal Implant System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Crown, Preformed | ELZ | 1 | Manufacturer | accessdata.fda.gov |
| Dental Abutment Design Software For Dental Laboratory | PNP | 2 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Complaint file establishment, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Plate, Bone | JEY | 2 | Complaint file establishment | accessdata.fda.gov |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | 2 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Intraosseous | DZL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 26, 2026 | K260061 | BioHorizons CEREC Compatible Ti-Bases | NHA | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| May 1, 2025 | K243521 | Conical Ti Base abutments | NHA | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| July 30, 2024 | K240531 | SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment | NHA | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| June 5, 2024 | K240187 | Tapered Pro Conical Implant System | DZE | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| October 13, 2023 | K223697 | MRI compatibility for existing BioHorizons dental implants and abutments | DZE | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| March 16, 2021 | K203252 | Multi-unit Abutments for CONELOG | NHA | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| October 10, 2018 | K182070 | BioHorizons Tapered IM Implants | DZE | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| September 28, 2018 | K180998 | BioHorizons CAD/CAM Bars | NHA | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| November 22, 2017 | K172576 | BioHorizons Tapered Short Implants | DZE | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| January 13, 2016 | K151621 | BioHorizons CAD/CAM Abutments | NHA | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| January 8, 2015 | K143022 | BioHorizons Tapered Internal Implants | DZE | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| March 20, 2014 | K133613 | INTRA-LOCK DENTAL IMPLANTS | DZE | Substantially Equivalent | Intra-Lock International, Inc. | accessdata.fda.gov |
| August 1, 2013 | K130140 | INTRA-LOCK OP DENTAL IMPLANT | DZE | Substantially Equivalent | Intra-Lock International | accessdata.fda.gov |
| September 5, 2012 | K121787 | BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS | DZE | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| November 3, 2011 | K103691 | BIOHORIZONS ABUTMENTS FOR ZIMMER | NHA | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| August 8, 2011 | K111199 | INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS | NHA | Substantially Equivalent | Intra-Lock International, Inc. | accessdata.fda.gov |
| April 21, 2011 | K103194 | INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM | DZE | Substantially Equivalent | Intra-Lock International, Inc. | accessdata.fda.gov |
| September 9, 2010 | K100985 | BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK | NHA | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| April 2, 2010 | K093321 | BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM | DZE | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| November 13, 2008 | K081818 | BIOLOK MICRO-LOK IMPLANT SYSTEM | DZE | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| May 21, 2008 | K080598 | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS | NHA | Substantially Equivalent | Intra-Lock International | accessdata.fda.gov |
| February 15, 2008 | K073282 | BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM | DZE | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| February 14, 2008 | K080074 | ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX | DZE | Substantially Equivalent | Ace Surgical Supply Co., Inc. | accessdata.fda.gov |
| February 8, 2008 | K073268 | BIOHORIZONS INTERNAL IMPLANT SYSTEM | DZE | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| October 12, 2007 | K070601 | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Intra-Lock International | accessdata.fda.gov |
| October 10, 2007 | K071638 | BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM | DZE | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| February 14, 2006 | K053099 | BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS | NHA | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| December 2, 2005 | K053152 | BIOHORIZONS SINGLE-STAGE IMPLANT | DZE | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| October 14, 2005 | K050970 | MILO DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Intra-Lock International | accessdata.fda.gov |
| September 16, 2004 | K042429 | THE PRODIGY SYSTEM DENTAL IMPLANTS | DZE | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| March 22, 2004 | K040205 | INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS | NHA | Substantially Equivalent | Intra-Lock International | accessdata.fda.gov |
| February 26, 2003 | K030463 | MODIFICATION TO THE MAESTRO SYSTEM | DZE | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| August 30, 2002 | K022795 | MODIFICATION TO THE MAESTRO SYSTEM | NHA | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| August 28, 2002 | K022790 | THE AUTOTAC SYSTEM TITANIUM TACK | DZL | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| July 24, 2002 | K021322 | ENDOSSOUS IMPLANTS | DZE | Substantially Equivalent | Intra-Lock International | accessdata.fda.gov |
| June 22, 2001 | K011675 | THE AUTOTAC SYSTEM | DZL | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| January 7, 2000 | K993493 | THE AUTOTAC SYSTEM | DZL | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| September 16, 1997 | K972313 | THE MAESTRO SYSTEM | DZE | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| January 17, 1997 | K964330 | BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE) | DZE | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| March 28, 1996 | K960026 | BIOHORIZONS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | BioHorizons Implant Systems, Inc. | accessdata.fda.gov |
| August 25, 1995 | K951510 | ACE BONE SCREW TACKING KIT | DZL | Substantially Equivalent | Ace Surgical Supply Co., Inc. | accessdata.fda.gov |
| May 5, 1995 | K951392 | MINIBONEPLATE SYSTEM | JEY | Substantially Equivalent | Ace Surgical Supply Co., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 30, 2015 | 72598 | Class II | Terminated | RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant | An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging. | accessdata.fda.gov |
| April 16, 2015 | 71125 | Class II | Terminated | Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement | 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. | accessdata.fda.gov |
| December 10, 2013 | 67090 | Class II | Terminated | 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 | The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length. | accessdata.fda.gov |
| November 19, 2012 | 63744 | Class II | Terminated | AutoTac Delivery Handle, REF, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental. | The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use. | accessdata.fda.gov |
| September 7, 2010 | 56785 | Not yet classified | Terminated | 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. | Healing abutment may not fully seat on the implant. | accessdata.fda.gov |
| April 18, 2007 | 37893 | Not yet classified | Terminated | Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243 | Dental implant system is missing ball attachment system. | accessdata.fda.gov |
| March 12, 2007 | 37687 | Not yet classified | Terminated | BioHorizons 0.035 Hex Driver, REF, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only, REF. | Premature wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear. | accessdata.fda.gov |
| December 28, 2005 | 36764 | Not yet classified | Terminated | BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit | Dental implants were distributed which lacked the proper instruments for implantation. | accessdata.fda.gov |
| June 3, 2005 | 32335 | Not yet classified | Terminated | The Maestro System, Straight Permucosal Ext, 5mm x 3mm | The product labeled as a Straight Permucosal Ext, 5mm x 3mm contained a profile abutment for Cement. | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Screw, Fixation, Intraosseous
- All makers of Crown, Preformed
- All makers of Dental Abutment Design Software For Dental Laboratory
- All makers of Platelet And Plasma Separator For Bone Graft Handling
Updated June 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.