Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Dent-All, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
64 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030161 | SUPERBOND | American Dent-All, Inc. | 2003-03-17 | 60 | 0 |
| K011706 | FLEXICAST PRIME | American Dent-All, Inc. | 2001-08-06 | 63 | 0 |
| K011705 | SUPREMCAST | American Dent-All, Inc. | 2001-08-03 | 60 | 0 |
| K003509 | FLEXICAST | American Dent-All, Inc. | 2001-01-02 | 49 | 0 |
| K001383 | SUPREMCAST V | American Dent-All, Inc. | 2000-07-05 | 64 | 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