Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pacific Union Dental, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
73 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K863500 | STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR | Pacific Union Dental, Inc. | 1986-09-22 | 13 | 0 |
| K860817 | ROOT CANAL ORGANIZER | Pacific Union Dental, Inc. | 1986-03-17 | 13 | 0 |
| K855112 | DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYS | Pacific Union Dental, Inc. | 1986-03-06 | 73 | 0 |
| K855111 | DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES | Pacific Union Dental, Inc. | 1986-03-06 | 73 | 0 |
| K855113 | FLOSS HOLDER (PLASTIC) | Pacific Union Dental, Inc. | 1986-03-06 | 73 | 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