Manufacturer registered with FDA
BioHorizons Implant Systems, Inc.
Birmingham, AL, United States. Lists 7 dental device types with FDA across 1 registered establishment, and holds 41 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 51
- 510(k) clearances
- 411996–2026
- Markets registered in
- 141,063 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 14 markets
Where regulators' registries name BioHorizons Implant Systems, Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | BioHorizons Implant Systems, Inc. | 41 clearances | 1996–2026 | Below |
| Canada | Health Canada | Registration holder | BIOHORIZONS IMPLANT SYSTEMS INC. | 619 | 1999–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | BioHorizons Implant Systems Inc | 79 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | BIOHORIZONS IMPLANT SYSTEMS,INC | 63 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | BioHorizons Implant Systems, Inc | 60 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Biohorizons Implant Systems Inc | 56 | 2006–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | BioHorizons Implant Systems, Inc. | 56 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | BioHorizons Implant Systems, Inc.BioHorizons Implant Systems, Inc · BioHorizons Implant Systems, Inc., · +2 | 43 | 1999–2010 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | BioHorizons Implant Systems Inc. | 40 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BIOHORIZONS IMPLANT SYSTEMS, INC. | 32 | 2007–2024 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | BioHorizons Implant Systems Inc.BioHorizons Implant Systems, Inc. | 7 | 2025–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | BIOHORIZONS IMPLANT SYSTEMS, INC | 5 | 2015–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | BioHorizons Implant Systems, Inc | 2 | — | Pure Global AI |
| China | NMPA | Registration holder | 美国百好瑞种植系统有限公司BioHorizons Implant Systems, Inc. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What BioHorizons Implant Systems, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | ACE SURIGICAL TRU-FIX IMPLANT SYSTEMBioHorizons Dental Implant SystemBioHorizons Internal Implant SystemBioHorizons Laser-Lok 3 Implant SystemBioHorizons Single-stage ImplantBioHorizons Single-stage Implant SystemBioHorizons Tapered Internal Implant SystemBioHorizons Tapered Internal ImplantsBioHorizons Tapered Internal Plus ImplantsBioHorizons Tapered Short Implants 13 moreBiolok Micro-Lok Implant SystemIntra-Lock Dental ImplantsIntra-Lock Dental Implants with BlossomIntra-Lock Endosseous ImplantsIntra-Lock Op Dental ImplantsMaestro SystemMilo Dental Implant SystemMini Drive-Lock Dental Implant SystemMRI compatibility for existing BioHorizons dental implants and abutmentsTapered IM ImplantsTapered Pro Conical Implant SystemThe Maestro SystemThe Prodigy System Dental Implants | 1996 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | BioHorizons Abutments for ZimmerBioHorizons CAD/CAM AbutmentsBioHorizons Laser-Lok 3 Implant SystemBioHorizons Plastic Temporary AbutmentsBioHorizons Simple Solutions with Laser-LokBioHorizons Tapered Internal Implant SystemCAD/CAM BarsCEREC Compatible Ti-BasesConical Ti Base AbutmentsIntra-Lock Angled Prosthetic Abutments 10 moreIntra-Lock Dental Implants with BlossomIntra-Lock Dental Implants with Blossom 3.4mm Implant Angled AbutmentsIntra-Lock Endosseous ImplantsMaestro SystemMilo Dental Implant SystemMini Drive-Lock Dental Implant System ProstheticsMRI compatibility for existing BioHorizons dental implants and abutmentsMulti-unit Abutments for CONELOGSmartShape Healing Abutment; Wide Custom Milled Ti-Blank AbutmentTapered Pro Conical Implant System | 2003 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | ACE BONE SCREW TACKING KITThe Autotac SystemThe Autotac System Titanium Tack | 2001 |
| Dental Abutment Design Software for Dental LaboratoryPNP · Class 2 | Dental design & orthodontic software | Maker | CEREC Compatible Ti-BasesConical Ti Base Abutments | 2025 |
| Preformed CrownELZ · Class 1 | — | Maker | BIOHORIZONS COMFORT CAP | 2005 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Lister | MINIBONEPLATE SYSTEM | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | BIOHORIZONS DENTAL IMPLANT ACCESSORIES | 2009 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names BioHorizons Implant Systems, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 26 Jun 2026 | K260061 | BioHorizons CEREC Compatible Ti-Bases | NHA Endosseous Dental Implant Abutment |
| 1 May 2025 | K243521 | Conical Ti Base abutments | NHA Endosseous Dental Implant Abutment |
| 30 Jul 2024 | K240531 | SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment | NHA Endosseous Dental Implant Abutment |
| 5 Jun 2024 | K240187 | Tapered Pro Conical Implant System | DZE Root-Form Endosseous Implant |
| 13 Oct 2023 | K223697 | MRI compatibility for existing BioHorizons dental implants and abutments | DZE Root-Form Endosseous Implant |
| 16 Mar 2021 | K203252 | Multi-unit Abutments for CONELOG | NHA Endosseous Dental Implant Abutment |
| 10 Oct 2018 | K182070 | BioHorizons Tapered IM Implants | DZE Root-Form Endosseous Implant |
| 28 Sep 2018 | K180998 | BioHorizons CAD/CAM Bars | NHA Endosseous Dental Implant Abutment |
| 22 Nov 2017 | K172576 | BioHorizons Tapered Short Implants | DZE Root-Form Endosseous Implant |
| 13 Jan 2016 | K151621 | BioHorizons CAD/CAM Abutments | NHA Endosseous Dental Implant Abutment |
| 8 Jan 2015 | K143022 | BioHorizons Tapered Internal Implants | DZE Root-Form Endosseous Implant |
| 5 Sep 2012 | K121787 | BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS | DZE Root-Form Endosseous Implant |
| 4 Nov 2011 | K103291 | BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE | NHA Endosseous Dental Implant Abutment |
| 3 Nov 2011 | K103691 | BIOHORIZONS ABUTMENTS FOR ZIMMER | NHA Endosseous Dental Implant Abutment |
| 9 Sep 2010 | K100985 | BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK | NHA Endosseous Dental Implant Abutment |
| 2 Apr 2010 | K093321 | BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 13 Nov 2008 | K081818 | BIOLOK MICRO-LOK IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 15 Feb 2008 | K073282 | BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 8 Feb 2008 | K073268 | BIOHORIZONS INTERNAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 10 Oct 2007 | K071638 | BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 22 Nov 2006 | K061567 | BIOHORIZONS CERAMIC ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 14 Feb 2006 | K053099 | BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 2 Dec 2005 | K053152 | BIOHORIZONS SINGLE-STAGE IMPLANT | DZE Root-Form Endosseous Implant |
| 20 Sep 2005 | K052419 | MAXIMUS 3.0 AND OS IMPLANTS | DZE Root-Form Endosseous Implant |
| 16 Sep 2004 | K042429 | THE PRODIGY SYSTEM DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 22 Jul 2004 | K041938 | MAXIMUS OS (OVERDENTURE SYSTEM) | DZE Root-Form Endosseous Implant |
| 21 Oct 2003 | K032351 | THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT | DZE Root-Form Endosseous Implant |
| 26 Feb 2003 | K030463 | MODIFICATION TO THE MAESTRO SYSTEM | DZE Root-Form Endosseous Implant |
| 30 Aug 2002 | K022795 | MODIFICATION TO THE MAESTRO SYSTEM | NHA Endosseous Dental Implant Abutment |
| 28 Aug 2002 | K022790 | THE AUTOTAC SYSTEM TITANIUM TACK | DZL Intraosseous Fixation Screw |
| 15 Mar 2002 | K020645 | MODIFICATION TO THE MAESTRO SYSTEM | DZE Root-Form Endosseous Implant |
| 25 Jan 2002 | K020133 | MODIFICATION TO THE MAESTRO SYSTEM | DZE Root-Form Endosseous Implant |
| 22 Jun 2001 | K011675 | THE AUTOTAC SYSTEM | DZL Intraosseous Fixation Screw |
| 10 May 2001 | K010458 | THE MAESTRO SYSTEM | DZE Root-Form Endosseous Implant |
| 7 Jan 2000 | K993493 | THE AUTOTAC SYSTEM | DZL Intraosseous Fixation Screw |
| 9 Apr 1999 | K990277 | O-RING ABUTMENT | DZE Root-Form Endosseous Implant |
| 4 Mar 1998 | K980374 | IMPLANT SITE DILATORS | DZE Root-Form Endosseous Implant |
| 16 Sep 1997 | K972313 | THE MAESTRO SYSTEM | DZE Root-Form Endosseous Implant |
| 17 Jan 1997 | K964330 | BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE) | DZE Root-Form Endosseous Implant |
| 31 Dec 1996 | K963951 | AS 123 PROSTHETIC INSTRUMENTATION SYSTEM | DZE Root-Form Endosseous Implant |
| 28 Mar 1996 | K960026 | BIOHORIZONS DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Digital Age Dental Laboratories, Ltd. (2), Smart Denture Conversions, LLC (1).
Also lists devices cleared under other names
BioHorizons Implant Systems, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Intra-Lock International, Inc. (9), Ace Surgical Supply Company, Inc. (3).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 20 Mar 2014 | K133613 | INTRA-LOCK DENTAL IMPLANTS | Intra-Lock International, Inc. | DZE Root-Form Endosseous Implant |
| 1 Aug 2013 | K130140 | INTRA-LOCK OP DENTAL IMPLANT | Intra-Lock International, Inc. | DZE Root-Form Endosseous Implant |
| 8 Aug 2011 | K111199 | INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS | Intra-Lock International, Inc. | NHA Endosseous Dental Implant Abutment |
| 21 Apr 2011 | K103194 | INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM | Intra-Lock International, Inc. | DZE Root-Form Endosseous Implant |
| 21 May 2008 | K080598 | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS | Intra-Lock International, Inc. | NHA Endosseous Dental Implant Abutment |
| 14 Feb 2008 | K080074 | ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX | Ace Surgical Supply Company, Inc. | DZE Root-Form Endosseous Implant |
| 12 Oct 2007 | K070601 | MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM | Intra-Lock International, Inc. | DZE Root-Form Endosseous Implant |
| 14 Oct 2005 | K050970 | MILO DENTAL IMPLANT SYSTEM | Intra-Lock International, Inc. | DZE Root-Form Endosseous Implant |
| 22 Mar 2004 | K040205 | INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS | Intra-Lock International, Inc. | NHA Endosseous Dental Implant Abutment |
| 24 Jul 2002 | K021322 | ENDOSSOUS IMPLANTS | Intra-Lock International, Inc. | DZE Root-Form Endosseous Implant |
| 25 Aug 1995 | K951510 | ACE BONE SCREW TACKING KIT | Ace Surgical Supply Company, Inc. | DZL Intraosseous Fixation Screw |
| 5 May 1995 | K951392 | MINIBONEPLATE SYSTEM | Ace Surgical Supply Company, Inc. | JEY Bone Plate |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BIOHORIZONS IMPLANT SYSTEMS INC.FDA reg. 1060818 | BIRMINGHAM, AL, United States | Complaint file establishment, Manufacturer for export, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9024113). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.