BioHorizons Implant Systems, Inc.: FDA clearances and approvals
BioHorizons Implant Systems, Inc. has 41 FDA 510(k) clearances (first 1996, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time: 86 days. Since 2017 its median was 158 days, against 192 days for all cleared 510(k)s in the same product codes. openFDA lists 14 product recalls by a recalling firm named BioHorizons Implant Systems, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 79 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 79 |
| 2016 | 1 | 211 |
| 2017 | 1 | 86 |
| 2018 | 2 | 118 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 132 |
| 2022 | 0 | — |
| 2023 | 1 | 308 |
| 2024 | 2 | 146 |
| 2025 | 1 | 169 |
| 2026 | 1 | 169 |
Review time against the same product codes
Since 2017, BioHorizons Implant Systems, Inc.'s cleared 510(k)s took a median 158 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 192 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 26 | 26 |
| NHA | Abutment, Implant, Dental, Endosseous | 12 | 12 |
| DZL | Screw, Fixation, Intraosseous | 3 | 3 |
Review panels
- Dental (41)
Most recent BioHorizons Implant Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260061 | BioHorizons CEREC Compatible Ti-Bases | NHA | 2026-06-26 | 169 |
| K243521 | Conical Ti Base abutments | NHA | 2025-05-01 | 169 |
| K240531 | SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment | NHA | 2024-07-30 | 158 |
| K240187 | Tapered Pro Conical Implant System | DZE | 2024-06-05 | 133 |
| K223697 | MRI compatibility for existing BioHorizons dental implants and abutments | DZE | 2023-10-13 | 308 |
| K203252 | Multi-unit Abutments for CONELOG | NHA | 2021-03-16 | 132 |
| K182070 | BioHorizons Tapered IM Implants | DZE | 2018-10-10 | 70 |
| K180998 | BioHorizons CAD/CAM Bars | NHA | 2018-09-28 | 165 |
| K172576 | BioHorizons Tapered Short Implants | DZE | 2017-11-22 | 86 |
| K151621 | BioHorizons CAD/CAM Abutments | NHA | 2016-01-13 | 211 |
31 earlier clearances. See the full list in Caduvo.
Recalls
14 product recalls in 9 recall events; 0 initiated in the last five years. Most recent: 2015-10-30.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does BioHorizons Implant Systems, Inc. have?
BioHorizons Implant Systems, Inc. has 41 FDA 510(k) clearances (first 1996, latest 2026), across 3 product codes in 1 review panel.
How long does FDA take to clear BioHorizons Implant Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across BioHorizons Implant Systems, Inc.'s cleared 510(k)s is 86 days. Since 2017: 158 days, versus 192 days for all cleared 510(k)s in the same product codes.
What devices does BioHorizons Implant Systems, Inc. make?
Its most frequent FDA product codes are DZE (Implant, Endosseous, Root-Form, 26); NHA (Abutment, Implant, Dental, Endosseous, 12); DZL (Screw, Fixation, Intraosseous, 3).
Has BioHorizons Implant Systems, Inc. had device recalls?
openFDA lists 14 product recalls in 9 recall events by a recalling firm whose name matches BioHorizons Implant Systems, Inc; the most recent began 2015-10-30. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 41 BioHorizons Implant Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, BioHorizons Implant Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.