Opti-Max: FDA clearances and approvals
Opti-Max has 6 FDA 510(k) clearances (first 1995, latest 1997), across 1 product code in 1 review panel. Median 510(k) review time: 128 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 6 | 6 |
Review panels
- Dental (6)
Most recent Opti-Max 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972769 | OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN 15 DEGREE AND 25 DEGREE INCLINATIONS. FOR IMPLANTS 3.3MM, 4 | DZE | 1997-11-13 | 112 |
| K960022 | OPTI-MAX BODY DIAMETER W/5MM TOP W/EXTERNAL HEX, EXTERNALLY THREADED DENTAL IMPLANT COARSE THREADS | DZE | 1996-05-24 | 143 |
| K955332 | OPTI-MAX EXTERNALLY THREADED CYLINDRICAL INTERNAL BORE DENTAL IMPLANT, WITH HEALING SCREW | DZE | 1996-05-06 | 168 |
| K952592 | OPTI-MAX INTERNAL-HEX ANGLED IMPLANT CROWN POST, 10 DEGREE & 20 DEGREE INCLINATIONS | DZE | 1995-09-21 | 108 |
| K952634 | OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW | DZE | 1995-09-18 | 102 |
| K944943 | OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL | DZE | 1995-03-13 | 157 |
Recalls
openFDA lists no recalls under a recalling firm named Opti-Max.
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 Opti-Max have?
Opti-Max has 6 FDA 510(k) clearances (first 1995, latest 1997), across 1 product code in 1 review panel.
How long does FDA take to clear Opti-Max's 510(k)s?
The median time from FDA receipt to decision across Opti-Max's cleared 510(k)s is 128 days.
What devices does Opti-Max make?
Its most frequent FDA product codes are DZE (Implant, Endosseous, Root-Form, 6).
Has Opti-Max had device recalls?
openFDA lists no recalls under a recalling firm name matching Opti-Max. Related entities may recall under other names.
Next steps
- See all 6 Opti-Max clearances with predicates and recalls
- Run predicate analysis for product code DZE, Opti-Max'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.