Manufacturer registered with FDA
Dentscare Ltda
Joinville, Brazil. Lists 14 dental device types with FDA across 1 registered establishment, and holds 10 510(k) clearances as applicant.
- Device types listed
- 14
- Brands and models
- 51
- 510(k) clearances
- 102019–2024
- Markets registered in
- 111,238 registrations outside the US
- Establishments
- 1Brazil
510(k) clearances per year, 2007–2026
Registered in 11 markets
Where regulators' registries name Dentscare Ltda as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Dentscare Ltda | 10 clearances | 2019–2024 | Below |
| Colombia | INVIMA | Registration holder | DENTSCARE LTDA.DENTSCARE LTDA | 964 | — | Pure Global AI |
| Brazil | ANVISA | Registration holder | DENTSCARE LTDA | 102 | 2004–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DENTSCARE LTDADENTSCARE LTDA. · DENTSCARE Ltda. | 66 | 2010–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Dentscare Ltda | 28 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | DENTSCARE LTDA | 26 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | DENTSCARE LTDA | 24 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Dentscare Ltda | 11 | 2025–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Dentscare Ltda | 10 | 2011–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DENTSCARE LTDA | 5 | 2015–2025 | Pure Global AI |
| Canada | Health Canada | Registration holder | DENTSCARE LTDA | 2 | 2024–2024 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Dentscare Ltda currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | AllcemAllcem CoreAllcem Veneer APSAllcem Veneer Try-inLlisOpus Bulk Fill APSOpus Bulk Fill Flow APSOrtho BiteOrthocemVittra APS 2 moreVittra APS Unique10055009 | 2019 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Maker | Ortho BiteOrthocem | 2020 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | Whitepost DC DrillWhitepost DC-E DrillWhitepost System DC DrillWhitepost System DC FitWhitepost System DC-E Drill | 2018 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | 10055009 | 2024 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | 3007210751 | 2025 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | TOP DAM 1GTOP DAM 2G | 2017 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Arcflex | 2017 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Maker | DiamondDiamond FlexDiamond Pro | 2018 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Diamond ACI & ACIIDiamond ExcelDiamond Excel UltrafineDiamond MasterDiamond R | 2018 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | Whitepost DCWhitepost DC-EWhitepost System DC FIT IntroWhitepost System DC FIT RefillWhitepost System DC FIT Refill MixWhitepost System DC IntroWhitepost System DC KitWhitepost System DC RefillWhitepost System DC Refill MixWhitepost System DC-E Intro 3 moreWhitepost System DC-E KitWhitepost System DC-E RefillWhitepost System DC-E Refill Mix | 2018 |
| Dental CementEMA · Class 2 | Dental cements | Maker | AllcemAllcem Core | 2019 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | Ambar APSAmbar Universal APS | 2019 |
| Resin ApplicatorKXR · Class 1 | — | Lister | Allcem Core Mixing tips | 2020 |
| Resin Long-Term Temporary Crown and BridgePOW · Class 2 | — | Maker | 3007210751 | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Dentscare Ltda as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 26 Nov 2024 | K231859 | PrimmaArt | EBG Resin Temporary Crown and Bridge |
| 18 Oct 2024 | K232994 | Vittra APS Unique Flow | EBF Resin Tooth Shade Material |
| 14 Oct 2021 | K210231 | Vittra APS Unique | EBF Resin Tooth Shade Material |
| 22 Dec 2020 | K201707 | Opallis, Opallis Flow | EBF Resin Tooth Shade Material |
| 14 Aug 2020 | K192682 | Orthocem, Ortho Bite | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 25 Feb 2020 | K191389 | Allcem Veneer APS | EBF Resin Tooth Shade Material |
| 16 Dec 2019 | K191306 | Llis, Vittra APS | EBF Resin Tooth Shade Material |
| 13 Dec 2019 | K183424 | Ambar, Ambar APS, Ambar Universal APS | KLE Resin Tooth Bonding Agent |
| 2 Nov 2019 | K183465 | Allcem, Allcem Core | EMA Dental Cement |
| 4 Sep 2019 | K190758 | Opus Bulk Fill APS, Opus Bulk Fill Flow APS | EBF Resin Tooth Shade Material |
Some of these clearances are listed with FDA today by another company: HEXA Dental (5).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTSCARE LTDAFDA reg. 3007210751 | Joinville Santa Catarina, Brazil | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10055009). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.