Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dentscare Ltda — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
323 daysmedian FDA review time
522 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231859 | PrimmaArt | Dentscare Ltda | 2024-11-26 | 522 | 0 |
| K232994 | Vittra APS Unique Flow | Dentscare Ltda | 2024-10-18 | 392 | 0 |
| K210231 | Vittra APS Unique | Dentscare Ltda | 2021-10-14 | 259 | 0 |
| K201707 | Opallis, Opallis Flow | Dentscare Ltda | 2020-12-22 | 183 | 0 |
| K192682 | Orthocem, Ortho Bite | Dentscare Ltda | 2020-08-14 | 323 | 0 |
| K191389 | Allcem Veneer APS | Dentscare Ltda | 2020-02-25 | 277 | 0 |
| K191306 | Llis, Vittra APS | Dentscare Ltda | 2019-12-16 | 216 | 0 |
| K183424 | Ambar, Ambar APS, Ambar Universal APS | Dentscare Ltda | 2019-12-13 | 367 | 0 |
| K183465 | Allcem, Allcem Core | Dentscare Ltda | 2019-11-02 | 323 | 0 |
| K190758 | Opus Bulk Fill APS, Opus Bulk Fill Flow APS | Dentscare Ltda | 2019-09-04 | 163 | 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