Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Park Dental Research Corp. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252976 | Park Dental Nylon MAD | Park Dental Research Corp. | 2025-12-18 | 92 | 0 |
| K121707 | LEW MDI O-BALL COLLARED IMPLANT, | Park Dental Research Corp. | 2012-09-24 | 105 | 0 |
| K082800 | STAR/VENT INTERNAL HEX SCREW IMPLANT | Park Dental Research Corp. | 2010-08-26 | 701 | 0 |
| K854749 | STARTANIUS DENTAL IMPLANT SYSTEM | Park Dental Research Corp. | 1986-03-06 | 100 | 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