Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alpha-Dent · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
233 daysmedian FDA review time
239 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932828 | CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE | Alpha-Dent | 1994-02-03 | 239 | 0 |
| K932826 | CENTRIX'S ENCORE COMPOSITE RESIN CORE PASTE W\FLUO | Alpha-Dent | 1994-01-28 | 233 | 0 |
| K932829 | CENTRIX'S ENCORE NATURAL COMPOSITE RESIN CORE PAST | Alpha-Dent | 1994-01-28 | 233 | 0 |
| K932827 | ALPHA-DENT CORE BUILDUP PASTE | Alpha-Dent | 1993-09-23 | 106 | 0 |
| K904813 | VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT. | Alpha-Dent | 1991-05-31 | 218 | 0 |
| K904812 | COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE | Alpha-Dent | 1991-02-26 | 124 | 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