Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kay See Dental Mfg. Co. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
37 daysmedian FDA review time
49 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001309 | HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MO | Kay See Dental Mfg. Co. | 2000-06-13 | 49 | 0 |
| K992609 | HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 | Kay See Dental Mfg. Co. | 1999-09-22 | 49 | 0 |
| K991161 | HYDRO-CAST ACRYLIC VARNISH, MODEL 78125 | Kay See Dental Mfg. Co. | 1999-04-29 | 22 | 0 |
| K990306 | HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 | Kay See Dental Mfg. Co. | 1999-03-03 | 30 | 0 |
| K990155 | HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL | Kay See Dental Mfg. Co. | 1999-02-25 | 37 | 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