Dentscare Ltda
Active in EUDAMEDBrazilfrom SRN EUDAMED FDA SRN BR-MF-000004013 FEI 3007210751
- Devices
- 437
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
- Authorised rep.
- Nuno FloresPT
What Dentscare Ltda makes
Dentscare Ltda manufactures dental composite resins, preformed root canal posts, dentifrices, dentine bonding agents, reusable steel dental burs, orthodontic bracket adhesives, and single-use injection cannulas for dental materials. Their portfolio includes specific products like Allcem Catalisador 2, Dual Cem A1 B/CAT, Llis, and the Whitepost System, designed for restorative, adhesive, and orthodontic applications in dentistry.
The company’s devices are regulated under EUDAMED, FDA 510(k), and FDA UDI registries, with classifications spanning Class I, Class II, Class IIa, and Class III. Their products are listed for commercialisation in Brazil and the European Union, adhering to applicable medical device regulations.
Catalogue
Search and filter all 437 devicesShowing 1-50 of 437
Company details
- EUDAMED SRN
- BR-MF-000004013
- FDA FEI number
- 3007210751
- DUNS number
- 898067533
- EUDAMED status
- Active
- EUDAMED registered name
- Dentscare Ltda
- Registered address
- 474, Av. Edgar Nelson Meister, 89219-501, Joinville, Brazil
- Website
- www.fgmdentalgroup.com
- ra@fgm.ind.br
- PRRC contact
- Tiago Ribeiro
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 30 Mar 2030
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 759293 Active
Quality management system EU MDR
- Issued
- 1 Apr 2026
- Expires
- 30 Mar 2030
- Reason
- Add device or group
Frequently asked questions
How many devices does Dentscare Ltda have in the registry?
The registry currently lists 437 devices for Dentscare Ltda. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dentscare Ltda's devices?
Among its 50 most recently registered devices, Dentscare Ltda has devices listed in EUDAMED (50 devices).
What risk classes do Dentscare Ltda's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Dentscare Ltda's devices are Class I and Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Dentscare Ltda?
EUDAMED lists 1 certificate for Dentscare Ltda (quality management system) under MDR. The most recent was issued on 1 Apr 2026.
What are the newest devices from Dentscare Ltda in the registry?
The most recently registered devices listed for Dentscare Ltda include Diamond Pro Sorted 8/12mm, Brava Block Bleach 14L Sirona, Desensibilize KF 2% (NORD) and Brava Block A3 LT 14L Sirona.