Data / Medical devices / Brazil / Dentscare Ltda
Dentscare Ltda: FDA-registered device maker in Joinville Santa Catarina, Brazil, 10 510(k) clearances
Dentscare Ltda is registered with the FDA (registration 3007210751) in Joinville Santa Catarina, Brazil. It lists 14 device types. The FDA files 10 510(k) clearances under its listings, the newest dated November 26, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007210751
- Address
- Av. Edgar Nelson Meister, 474, Joinville Santa Catarina, Brazil, 89219-501
- Owner or operator
- Dentscare Ltda (10055009)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- June 27, 2017
- Registered through
- 2026
- Brand names listed
- 10055009, 3007210751, Allcem, Allcem Core, Allcem Core Mixing tips, Allcem Veneer APS, Allcem Veneer Try-in, Ambar APS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | 2 | Manufacturer | accessdata.fda.gov |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Manufacturer | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
| Applicator, Resin | KXR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Long-Term Temporary, Resin | POW | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Post, Root Canal | ELR | 1 | Manufacturer | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Manufacturer | accessdata.fda.gov |
| Sealant, Pit And Fissure, And Conditioner | EBC | 2 | Manufacturer | accessdata.fda.gov |
| Wheel, Polishing Agent | EJQ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 26, 2024 | K231859 | PrimmaArt | EBG | Substantially Equivalent | Dentscare Ltda | accessdata.fda.gov |
| October 18, 2024 | K232994 | Vittra APS Unique Flow | EBF | Substantially Equivalent | Dentscare Ltda | accessdata.fda.gov |
| October 14, 2021 | K210231 | Vittra APS Unique | EBF | Substantially Equivalent | Dentscare Ltda | accessdata.fda.gov |
| December 22, 2020 | K201707 | Opallis, Opallis Flow | EBF | Substantially Equivalent | Dentscare Ltda | accessdata.fda.gov |
| August 14, 2020 | K192682 | Orthocem, Ortho Bite | DYH | Substantially Equivalent | Dentscare Ltda | accessdata.fda.gov |
| February 25, 2020 | K191389 | Allcem Veneer APS | EBF | Substantially Equivalent | Dentscare Ltda | accessdata.fda.gov |
| December 16, 2019 | K191306 | Llis, Vittra APS | EBF | Substantially Equivalent | Dentscare Ltda | accessdata.fda.gov |
| December 13, 2019 | K183424 | Ambar, Ambar APS, Ambar Universal APS | KLE | Substantially Equivalent | Dentscare Ltda | accessdata.fda.gov |
| November 2, 2019 | K183465 | Allcem, Allcem Core | EMA | Substantially Equivalent | Dentscare Ltda | accessdata.fda.gov |
| September 4, 2019 | K190758 | Opus Bulk Fill APS, Opus Bulk Fill Flow APS | EBF | Substantially Equivalent | Dentscare Ltda | accessdata.fda.gov |
Compare with other makers
- All makers of Retractor, All Types
- All makers of Drill, Dental, Intraoral
- All makers of Material, Tooth Shade, Resin
- All makers of Applicator, Resin
- All makers of Dam, Rubber
- All makers of Cement, Dental
Updated November 26, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.