Dentscare Ltda: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Dentscare Ltda” (first 2019, latest 2024), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 300 days. Since 2017 the median was 300 days, against 117 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 |
|---|---|---|
| 2019 | 4 | 270 |
| 2020 | 3 | 277 |
| 2021 | 1 | 259 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 457 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Dentscare Ltda took a median 300 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 117 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 6 | 6 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
Review panels
- Dental (10)
Most recent Dentscare Ltda 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231859 | PrimmaArt | EBG | 2024-11-26 | 522 |
| K232994 | Vittra APS Unique Flow | EBF | 2024-10-18 | 392 |
| K210231 | Vittra APS Unique | EBF | 2021-10-14 | 259 |
| K201707 | Opallis, Opallis Flow | EBF | 2020-12-22 | 183 |
| K192682 | Orthocem, Ortho Bite | DYH | 2020-08-14 | 323 |
| K191389 | Allcem Veneer APS | EBF | 2020-02-25 | 277 |
| K191306 | Llis, Vittra APS | EBF | 2019-12-16 | 216 |
| K183424 | Ambar, Ambar APS, Ambar Universal APS | KLE | 2019-12-13 | 367 |
| K183465 | Allcem, Allcem Core | EMA | 2019-11-02 | 323 |
| K190758 | Opus Bulk Fill APS, Opus Bulk Fill Flow APS | EBF | 2019-09-04 | 163 |
Recalls
openFDA lists no recalls under a recalling firm named Dentscare Ltda.
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 Dentscare Ltda?
FDA lists 10 510(k) clearances under the applicant name “Dentscare Ltda” (first 2019, latest 2024), across 5 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 Dentscare Ltda?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dentscare Ltda is 300 days. Since 2017: 300 days, versus 117 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Dentscare Ltda?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 6); DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 1); EBG (Crown And Bridge, Temporary, Resin, 1).
Next steps
- See all 10 Dentscare Ltda clearances with predicates and recalls
- Run predicate analysis for product code EBF, Dentscare Ltda'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.