Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Opti-Max — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
143 daysmedian FDA review time
168 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972769 | OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN | Opti-Max | 1997-11-13 | 112 | 0 |
| K960022 | OPTI-MAX BODY DIAMETER W/5MM TOP W/EXTERNAL HEX, EXTERNALLY | Opti-Max | 1996-05-24 | 143 | 0 |
| K955332 | OPTI-MAX EXTERNALLY THREADED CYLINDRICAL INTERNAL BORE DENTA | Opti-Max | 1996-05-06 | 168 | 0 |
| K952592 | OPTI-MAX INTERNAL-HEX ANGLED IMPLANT CROWN POST, 10 DEGREE & | Opti-Max | 1995-09-21 | 108 | 0 |
| K952634 | OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TI | Opti-Max | 1995-09-18 | 102 | 0 |
| K944943 | OPTI-MAX PRESS-FIT EXTERNAL-HEX DENTAL | Opti-Max | 1995-03-13 | 157 | 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