Dentscare Ltda
Joinville Santa Catarina, BR
DENTSCARE LTDA appears in FDA device records in Joinville Santa Catarina, BR. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Dentscare Ltda between 2019 and 2024. The busiest year on record is 2019, with 4. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 4 |
| 2020 | 3 |
| 2021 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231859 | PrimmaArt | EBG | Substantially Equivalent | |
| K232994 | Vittra APS Unique Flow | EBF | Substantially Equivalent | |
| K210231 | Vittra APS Unique | EBF | Substantially Equivalent | |
| K201707 | Opallis, Opallis Flow | EBF | Substantially Equivalent | |
| K192682 | Orthocem, Ortho Bite | DYH | Substantially Equivalent | |
| K191389 | Allcem Veneer APS | EBF | Substantially Equivalent | |
| K191306 | Llis, Vittra APS | EBF | Substantially Equivalent | |
| K183424 | Ambar, Ambar APS, Ambar Universal APS | KLE | Substantially Equivalent | |
| K183465 | Allcem, Allcem Core | EMA | Substantially Equivalent | |
| K190758 | Opus Bulk Fill APS, Opus Bulk Fill Flow APS | EBF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007210751 | 3007210751 | DENTSCARE LTDA | Av. Edgar Nelson Meister, 474, Joinville Santa Catarina 89219-501 BR | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DYHAdhesive, Bracket And Tooth Conditioner, Resin
- EJRAgent, Polishing, Abrasive, Oral Cavity
- KLEAgent, Tooth Bonding, Resin
- KXRApplicator, Resin
- EMACement, Dental
- POWCrown And Bridge, Long-Term Temporary, Resin
- EBGCrown And Bridge, Temporary, Resin
- EIEDam, Rubber
- DZADrill, Dental, Intraoral
- EBFMaterial, Tooth Shade, Resin
- ELRPost, Root Canal
- EIGRetractor, All Types
- EBCSealant, Pit And Fissure, And Conditioner
- EJQWheel, Polishing Agent
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain