Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
American Dental Research · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
50 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K800389 | ANTERIOR & POST. RESTORATIVE PASTE SYS. | American Dental Research | 1980-04-10 | 50 | 0 |
| K800390 | ANT. & POST. RESTORATIVE POWDER LIQ. | American Dental Research | 1980-04-10 | 50 | 0 |
| K800391 | PAINT-ON-RESTORATIVE W/FISSURE SEALER | American Dental Research | 1980-04-10 | 50 | 0 |
| K800392 | BRACKET BONDING SYSTEM METAL & PLASTIC | American Dental Research | 1980-04-10 | 50 | 0 |
| K800393 | POLY SULFIDE IMPRESSION PASTE W/CATALYST | American Dental Research | 1980-04-10 | 50 | 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