Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Park Dental Research Corporation · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233935 | DigiLine Direct Print Aligner System | Park Dental Research Corporation | 2024-04-05 | 113 | 0 |
| K180648 | Park Dental Research Aligners | Park Dental Research Corporation | 2019-01-08 | 301 | 0 |
| K181220 | Juell 3D Volo Base | Park Dental Research Corporation | 2018-10-12 | 158 | 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