Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Prevest Denpro Limited · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
283 daysmedian FDA review time
436 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233273 | C&B Ceramic; C&B Permanent; C&B Interim | Prevest Denpro Limited | 2024-11-27 | 425 | 0 |
| K231263 | Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal | Prevest Denpro Limited | 2024-01-05 | 248 | 0 |
| K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Ren | Prevest Denpro Limited | 2023-08-11 | 60 | 0 |
| K213244 | Accusil Dental Impression Materials (Accusil Light Body Regu | Prevest Denpro Limited | 2022-09-09 | 344 | 0 |
| K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical U | Prevest Denpro Limited | 2022-05-23 | 283 | 0 |
| K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, | Prevest Denpro Limited | 2022-05-13 | 280 | 0 |
| K200555 | Prevest Denpro Dental Cements (Micron Bioactive, Micron Supe | Prevest Denpro Limited | 2021-05-13 | 436 | 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