← Back to catalogue
StarGloss RA - blau - Kelch
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref R2620RA-100Model 16412Ref R2620RA-6
Identity
- Trade Name
- StarGloss RA - blau - Kelch EUDAMEDEDENTA FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- Polierer / Arkansas EUDAMEDStarGloss RA - blue - cup FDA UDI
- Model / Reference
- 16412 EUDAMEDR2620RA-100 EUDAMEDR2620RA-6 EUDAMEDFDA UDI
- Description
- StarGloss RA - blue - cup FDA UDI
Identifiers
- Primary DI / UDI-DI
- E312R2620RA1001 EUDAMEDE312R2620RA61 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31216412DU EUDAMED
- Unit of Use DI
- E312R2620RA6101 EUDAMEDE312R2620RA100101 EUDAMED
- FDA Product Code
- EJQ FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
- GMDN Term
- Dental abrasive point, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6010 FDA UDI
- Market of Registration
- Liechtenstein EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
StarGloss RA - blau - Kelch by Edenta Etablissement — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E31216412DU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Edenta Etablissement
- EUDAMED SRN
- LI-MF-000011937
Sources (4)
- EUDAMED 891d2663-fedf-4673-9f86-5136fed94f58 61 fields · synced Jul 11, 2026
- EUDAMED 451f9db0-2b3f-4efd-aeb6-6f516c72c267 61 fields · synced May 19, 2026
- FDA UDI 2c843ae9-9a16-4e76-842e-c9fade0854de 33 fields · synced May 30, 2026
- EUDAMED bb29cf2f-3b6e-47c9-b838-2b86979afead 61 fields · synced Jul 11, 2026