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StarGloss RA - grau - Kelch
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref R2640RA-6Model 16412Ref R2640RA-100
Identity
- Trade Name
- StarGloss RA - grau - Kelch EUDAMEDEDENTA FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- Polierer / Arkansas EUDAMEDStarGloss RA - grey - cup FDA UDI
- Model / Reference
- 16412 EUDAMEDR2640RA-6 EUDAMEDFDA UDIR2640RA-100 EUDAMED
- Description
- StarGloss RA - grey - cup FDA UDI
Identifiers
- Primary DI / UDI-DI
- E312R2640RA61 EUDAMEDFDA UDIE312R2640RA1001 EUDAMED
- Basic UDI-DI
- ++E31216412DU EUDAMED
- Unit of Use DI
- E312R2640RA6101 EUDAMEDE312R2640RA100101 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 - grau - 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 |
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Manufacturer
- Manufacturer
- Edenta Etablissement
- EUDAMED SRN
- LI-MF-000011937
Sources (4)
- EUDAMED 25beaabb-a7cc-466e-8c1b-bb029395d362 61 fields · synced Jul 31, 2026
- EUDAMED f1b94c39-e0d1-465b-ad69-f1477bb5b905 61 fields · synced May 18, 2026
- FDA UDI 8b767698-1a60-45d7-a559-c846b19d67e2 33 fields · synced May 30, 2026
- EUDAMED 9792209b-a39d-4e62-805e-3b9c5ff04641 61 fields · synced Jul 31, 2026