Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pac-Dent International, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
146 daysmedian FDA review time
389 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162662 | GingiDent Gingival Retraction Paste | Pac-Dent International, Inc. | 2017-10-20 | 389 | 0 |
| K160577 | PacEndo Chlorhexidine | Pac-Dent International, Inc. | 2016-07-25 | 146 | 0 |
| K151123 | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film | Pac-Dent International, Inc. | 2016-03-03 | 310 | 0 |
| K153528 | PacEndo EDTA | Pac-Dent International, Inc. | 2016-02-01 | 54 | 0 |
| K151852 | PacEndo Sodium Hyprochlorite | Pac-Dent International, Inc. | 2015-11-10 | 126 | 0 |
| K151150 | Elements | Pac-Dent International, Inc. | 2015-07-28 | 89 | 0 |
| K141717 | PACSEAL PIT & FISSURE SEALANT | Pac-Dent International, Inc. | 2015-03-09 | 257 | 0 |
| K141422 | PROFLUORO FLUORIDE VARNISH | Pac-Dent International, Inc. | 2014-09-30 | 123 | 0 |
| K130672 | OPTIFLOW II FLOWABLE COMPOSITE, LC | Pac-Dent International, Inc. | 2013-08-13 | 154 | 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