Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medental Intl. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
136 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990314 | MULTI-CURE COMPOSITE CEMENT | Medental Intl. | 1999-04-02 | 60 | 0 |
| K983018 | ZINC PHOSPHATE CEMENT | Medental Intl. | 1998-10-22 | 55 | 0 |
| K982779 | MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOME | Medental Intl. | 1998-09-30 | 54 | 0 |
| K982191 | CHEMICAL CURE COMPOSITE WITH ENAMEL BOND | Medental Intl. | 1998-09-14 | 84 | 0 |
| K980990 | POLYCARBOXYLATE CEMENT | Medental Intl. | 1998-07-31 | 136 | 0 |
| K973919 | CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEA | Medental Intl. | 1997-12-16 | 62 | 0 |
| K973541 | MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED | Medental Intl. | 1997-11-25 | 68 | 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