Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BioHorizons Implant Systems, Inc. — Predicate Candidate Screening
41 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
169 days90th percentile
41clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260061 | BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems, Inc. | 2026-06-26 | 169 | 0 |
| K243521 | Conical Ti Base abutments | BioHorizons Implant Systems, Inc. | 2025-05-01 | 169 | 0 |
| K240531 | SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Ab | BioHorizons Implant Systems, Inc. | 2024-07-30 | 158 | 0 |
| K240187 | Tapered Pro Conical Implant System | BioHorizons Implant Systems, Inc. | 2024-06-05 | 133 | 0 |
| K223697 | MRI compatibility for existing BioHorizons dental implants a | BioHorizons Implant Systems, Inc. | 2023-10-13 | 308 | 1 |
| K203252 | Multi-unit Abutments for CONELOG | BioHorizons Implant Systems, Inc. | 2021-03-16 | 132 | 0 |
| K182070 | BioHorizons Tapered IM Implants | BioHorizons Implant Systems, Inc. | 2018-10-10 | 70 | 0 |
| K180998 | BioHorizons CAD/CAM Bars | BioHorizons Implant Systems, Inc. | 2018-09-28 | 165 | 0 |
| K172576 | BioHorizons Tapered Short Implants | BioHorizons Implant Systems, Inc. | 2017-11-22 | 86 | 0 |
| K151621 | BioHorizons CAD/CAM Abutments | BioHorizons Implant Systems, Inc. | 2016-01-13 | 211 | 0 |
| K143022 | BioHorizons Tapered Internal Implants | BioHorizons Implant Systems, Inc. | 2015-01-08 | 79 | 0 |
| K121787 | BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS | BioHorizons Implant Systems, Inc. | 2012-09-05 | 79 | 0 |
| K103291 | BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE | BioHorizons Implant Systems, Inc. | 2011-11-04 | 361 | 0 |
| K103691 | BIOHORIZONS ABUTMENTS FOR ZIMMER | BioHorizons Implant Systems, Inc. | 2011-11-03 | 321 | 1 |
| K100985 | BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK | BioHorizons Implant Systems, Inc. | 2010-09-09 | 153 | 0 |
| K093321 | BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | 2010-04-02 | 161 | 1 |
| K081818 | BIOLOK MICRO-LOK IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | 2008-11-13 | 139 | 0 |
| K073282 | BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | 2008-02-15 | 86 | 0 |
| K073268 | BIOHORIZONS INTERNAL IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | 2008-02-08 | 80 | 1 |
| K071638 | BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | 2007-10-10 | 117 | 2 |
| K061567 | BIOHORIZONS CERAMIC ABUTMENT | BioHorizons Implant Systems, Inc. | 2006-11-22 | 169 | 0 |
| K053099 | BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS | BioHorizons Implant Systems, Inc. | 2006-02-14 | 103 | 0 |
| K053152 | BIOHORIZONS SINGLE-STAGE IMPLANT | BioHorizons Implant Systems, Inc. | 2005-12-02 | 22 | 1 |
| K052419 | MAXIMUS 3.0 AND OS IMPLANTS | BioHorizons Implant Systems, Inc. | 2005-09-20 | 18 | 0 |
| K042429 | THE PRODIGY SYSTEM DENTAL IMPLANTS | BioHorizons Implant Systems, Inc. | 2004-09-16 | 8 | 0 |
| K041938 | MAXIMUS OS (OVERDENTURE SYSTEM) | BioHorizons Implant Systems, Inc. | 2004-07-22 | 3 | 2 |
| K032351 | THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT | BioHorizons Implant Systems, Inc. | 2003-10-21 | 83 | 0 |
| K030463 | MODIFICATION TO THE MAESTRO SYSTEM | BioHorizons Implant Systems, Inc. | 2003-02-26 | 14 | 1 |
| K022795 | MODIFICATION TO THE MAESTRO SYSTEM | BioHorizons Implant Systems, Inc. | 2002-08-30 | 7 | 0 |
| K022790 | THE AUTOTAC SYSTEM TITANIUM TACK | BioHorizons Implant Systems, Inc. | 2002-08-28 | 6 | 0 |
| K020645 | MODIFICATION TO THE MAESTRO SYSTEM | BioHorizons Implant Systems, Inc. | 2002-03-15 | 15 | 0 |
| K020133 | MODIFICATION TO THE MAESTRO SYSTEM | BioHorizons Implant Systems, Inc. | 2002-01-25 | 10 | 0 |
| K011675 | THE AUTOTAC SYSTEM | BioHorizons Implant Systems, Inc. | 2001-06-22 | 23 | 0 |
| K010458 | THE MAESTRO SYSTEM | BioHorizons Implant Systems, Inc. | 2001-05-10 | 83 | 0 |
| K993493 | THE AUTOTAC SYSTEM | BioHorizons Implant Systems, Inc. | 2000-01-07 | 84 | 1 |
| K990277 | O-RING ABUTMENT | BioHorizons Implant Systems, Inc. | 1999-04-09 | 71 | 0 |
| K980374 | IMPLANT SITE DILATORS | BioHorizons Implant Systems, Inc. | 1998-03-04 | 33 | 0 |
| K972313 | THE MAESTRO SYSTEM | BioHorizons Implant Systems, Inc. | 1997-09-16 | 88 | 0 |
| K964330 | BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE) | BioHorizons Implant Systems, Inc. | 1997-01-17 | 78 | 0 |
| K963951 | AS 123 PROSTHETIC INSTRUMENTATION SYSTEM | BioHorizons Implant Systems, Inc. | 1996-12-31 | 90 | 3 |
| K960026 | BIOHORIZONS DENTAL IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | 1996-03-28 | 86 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda