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StarGloss RA - pink - Lamelle
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref R2830RA-100Model 16412Ref R2830RA-6
Identity
- Trade Name
- StarGloss RA - pink - Lamelle EUDAMEDEDENTA FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- Polierer / Arkansas EUDAMEDStarGloss RA - pink - Lamella FDA UDI
- Model / Reference
- 16412 EUDAMEDR2830RA-100 EUDAMEDR2830RA-6 EUDAMEDFDA UDI
- Description
- StarGloss RA - pink - Lamella FDA UDI
Identifiers
- Catalog Number
- P2830RA-6 FDA UDI
- Primary DI / UDI-DI
- E312R2830RA1001 EUDAMEDE312R2830RA61 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31216412DU EUDAMED
- Unit of Use DI
- E312R2830RA6101 EUDAMEDE312R2830RA100101 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 - pink - Lamelle 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 a5c22a52-d23a-4a19-ac61-ae8a3cac94c7 61 fields · synced Jul 16, 2026
- EUDAMED 7ca2d971-1b46-4d91-a865-d8f0e0085498 61 fields · synced May 18, 2026
- FDA UDI 7ae18cca-8104-4aec-a442-0659195574d7 34 fields · synced May 30, 2026
- EUDAMED 3a5c18dd-088d-4e3f-8660-1247743d4bd8 61 fields · synced Jul 14, 2026