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TopGloss RA - Kelch
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 20035RA-25Model 16412Ref 20035RA-100
Identity
- Trade Name
- TopGloss RA - Kelch EUDAMEDEDENTA FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- Polierer / Arkansas EUDAMEDTopGloss RA - cup FDA UDI
- Model / Reference
- 16412 EUDAMED20035RA-25 EUDAMED20035RA-100 EUDAMEDFDA UDI
- Description
- TopGloss RA - cup FDA UDI
Identifiers
- Catalog Number
- P0735 FDA UDI
- Primary DI / UDI-DI
- E31220035RA251 EUDAMEDE31220035RA1001 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31216412DU EUDAMED
- Unit of Use DI
- E31220035RA100101 EUDAMEDE31220035RA25101 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
TopGloss RA - 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 6330a790-04c8-4949-9f41-c3e8a2b330a4 61 fields · synced Jul 31, 2026
- EUDAMED 70ac8ff2-88f1-4079-ada8-2cd1fbce7e87 61 fields · synced May 19, 2026
- FDA UDI 01d8fbea-0dd9-4243-8d63-c1999a53e271 34 fields · synced May 30, 2026
- EUDAMED f7c2356c-dd88-44bb-b76e-b6b4605e7785 61 fields · synced Jul 31, 2026