Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pac-Dent, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
294 daysmedian FDA review time
818 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202674 | Medidenta High Speed Handpieces | Pac-Dent, Inc. | 2022-12-12 | 818 | 0 |
| K202920 | OptiComp | Pac-Dent, Inc. | 2022-05-25 | 603 | 0 |
| K202831 | The iMask Child's Face Mask | Pac-Dent, Inc. | 2021-08-26 | 335 | 0 |
| K210189 | Pac-Dent Denture Base Resin | Pac-Dent, Inc. | 2021-07-28 | 184 | 0 |
| K210412 | Pac-Dent Ceramic Nanohybrid Resin | Pac-Dent, Inc. | 2021-07-26 | 165 | 0 |
| K210186 | PacBond One | Pac-Dent, Inc. | 2021-07-16 | 172 | 0 |
| K201182 | iMask Disposable Surgical Face Mask | Pac-Dent, Inc. | 2021-02-19 | 294 | 0 |
| K200330 | RC-Prime Root Canal Preparation Cream | Pac-Dent, Inc. | 2020-07-06 | 147 | 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