Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
S.S. White Mfg., Ltd. · 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) |
|---|---|---|---|---|---|
| K972935 | SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL | S.S. White Mfg., Ltd. | 1998-01-29 | 174 | 0 |
| K965083 | SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLE | S.S. White Mfg., Ltd. | 1997-04-04 | 106 | 0 |
| K964179 | SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER- | S.S. White Mfg., Ltd. | 1997-01-09 | 83 | 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