Prevest Denpro Limited: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Prevest Denpro Limited” (first 2021, latest 2024), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 283 days. Since 2017 the median was 283 days, against 111 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 436 |
| 2022 | 3 | 283 |
| 2023 | 1 | 60 |
| 2024 | 2 | 336 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Prevest Denpro Limited took a median 283 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 111 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
| KIF | Resin, Root Canal Filling | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
Review panels
- Dental (7)
Most recent Prevest Denpro Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233273 | C&B Ceramic; C&B Permanent; C&B Interim | EBF | 2024-11-27 | 425 |
| K231263 | Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT | EBF | 2024-01-05 | 248 |
| K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | KLE | 2023-08-11 | 60 |
| K213244 | Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) | ELW | 2022-09-09 | 344 |
| K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | KIF | 2022-05-23 | 283 |
| K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | EJK | 2022-05-13 | 280 |
| K200555 | Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) | EMA | 2021-05-13 | 436 |
Recalls
openFDA lists no recalls under a recalling firm named Prevest Denpro Limited.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Prevest Denpro Limited?
FDA lists 7 510(k) clearances under the applicant name “Prevest Denpro Limited” (first 2021, latest 2024), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Prevest Denpro Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Prevest Denpro Limited is 283 days. Since 2017: 283 days, versus 111 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Prevest Denpro Limited?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 2); EJK (Liner, Cavity, Calcium Hydroxide, 1); ELW (Material, Impression, 1).
Next steps
- See all 7 Prevest Denpro Limited clearances with predicates and recalls
- Run predicate analysis for product code EBF, Prevest Denpro Limited's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.