BioHorizons Implant Systems Inc
Birmingham, AL, US
BIOHORIZONS IMPLANT SYSTEMS INC. appears in FDA device records in Birmingham, AL. FDA records list 41 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 14 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 41 510(k) clearances for BioHorizons Implant Systems Inc between 1996 and 2026. The busiest year on record is 2002, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 2 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 4 |
| 2003 | 2 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 3 |
| 2010 | 2 |
| 2011 | 2 |
| 2012 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260061 | BioHorizons CEREC Compatible Ti-Bases | NHA | Substantially Equivalent | |
| K243521 | Conical Ti Base abutments | NHA | Substantially Equivalent | |
| K240531 | SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment | NHA | Substantially Equivalent | |
| K240187 | Tapered Pro Conical Implant System | DZE | Substantially Equivalent | |
| K223697 | MRI compatibility for existing BioHorizons dental implants and abutments | DZE | Substantially Equivalent | |
| K203252 | Multi-unit Abutments for CONELOG | NHA | Substantially Equivalent | |
| K182070 | BioHorizons Tapered IM Implants | DZE | Substantially Equivalent | |
| K180998 | BioHorizons CAD/CAM Bars | NHA | Substantially Equivalent | |
| K172576 | BioHorizons Tapered Short Implants | DZE | Substantially Equivalent | |
| K151621 | BioHorizons CAD/CAM Abutments | NHA | Substantially Equivalent | |
| K143022 | BioHorizons Tapered Internal Implants | DZE | Substantially Equivalent | |
| K121787 | BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS | DZE | Substantially Equivalent | |
| K103291 | BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE | NHA | Substantially Equivalent | |
| K103691 | BIOHORIZONS ABUTMENTS FOR ZIMMER | NHA | Substantially Equivalent | |
| K100985 | BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK | NHA | Substantially Equivalent | |
| K093321 | BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K081818 | BIOLOK MICRO-LOK IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K073282 | BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K073268 | BIOHORIZONS INTERNAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K071638 | BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K061567 | BIOHORIZONS CERAMIC ABUTMENT | NHA | Substantially Equivalent | |
| K053099 | BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS | NHA | Substantially Equivalent | |
| K053152 | BIOHORIZONS SINGLE-STAGE IMPLANT | DZE | Substantially Equivalent | |
| K052419 | MAXIMUS 3.0 AND OS IMPLANTS | DZE | Substantially Equivalent | |
| K042429 | THE PRODIGY SYSTEM DENTAL IMPLANTS | DZE | Substantially Equivalent | |
| K041938 | MAXIMUS OS (OVERDENTURE SYSTEM) | DZE | Substantially Equivalent | |
| K032351 | THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT | DZE | Substantially Equivalent | |
| K030463 | MODIFICATION TO THE MAESTRO SYSTEM | DZE | Substantially Equivalent | |
| K022795 | MODIFICATION TO THE MAESTRO SYSTEM | NHA | Substantially Equivalent | |
| K022790 | THE AUTOTAC SYSTEM TITANIUM TACK | DZL | Substantially Equivalent | |
| K020645 | MODIFICATION TO THE MAESTRO SYSTEM | DZE | Substantially Equivalent | |
| K020133 | MODIFICATION TO THE MAESTRO SYSTEM | DZE | Substantially Equivalent | |
| K011675 | THE AUTOTAC SYSTEM | DZL | Substantially Equivalent | |
| K010458 | THE MAESTRO SYSTEM | DZE | Substantially Equivalent | |
| K993493 | THE AUTOTAC SYSTEM | DZL | Substantially Equivalent | |
| K990277 | O-RING ABUTMENT | DZE | Substantially Equivalent | |
| K980374 | IMPLANT SITE DILATORS | DZE | Substantially Equivalent | |
| K972313 | THE MAESTRO SYSTEM | DZE | Substantially Equivalent | |
| K964330 | BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE) | DZE | Substantially Equivalent | |
| K963951 | AS 123 PROSTHETIC INSTRUMENTATION SYSTEM | DZE | Substantially Equivalent | |
| K960026 | BIOHORIZONS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1060818 | 1000592496 | BIOHORIZONS IMPLANT SYSTEMS INC. | 2300 RIVERCHASE CENTER, BIRMINGHAM, AL 35244 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0391-2016 | 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. | Class II | Terminated | |
| Z-1605-2015 | 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. | Class II | Terminated | |
| Z-1058-2014 | 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. | Class II | Terminated | |
| Z-0562-2013 | Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental. | The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use. | Class II | Terminated | |
| Z-0561-2013 | AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental. | The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use. | Class II | Terminated | |
| Z-0321-2011 | 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. | Terminated | ||
| Z-0801-2007 | 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. | Terminated | ||
| Z-1164-2007 | 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 , Manufactured by Innovision, Inc., and the kits are assembled by BioHorizons. | Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear. | Terminated | ||
| Z-0694-2007 | BioHorizons 0.050 Hex Driver, Long, REF 300-351, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only | Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear. | Terminated | ||
| Z-0693-2007 | BioHorizons 0.050 Hex Driver, Regular, REF 300-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only | Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear. | Terminated | ||
| Z-0692-2007 | BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only, REF 300-377. | Premature wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear. | Terminated | ||
| Z-0252-2007 | 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. | Terminated | ||
| Z-0926-05 | The Maestor System 225-312, Profile Abutment for Cement, 5mm | The product labeled as a profile abutment for Cement contained a Straight Permucosal Ext, 5mm x 3mm. | Terminated | ||
| Z-0925-05 | The Maestro System 204-503, Straight Permucosal Ext, 5mm x 3mm | The product labeled as a Straight Permucosal Ext, 5mm x 3mm contained a profile abutment for Cement. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain