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KENDA Complete Pre-Polishers for Composite/Compomer/Gold/Amalgam, Point, RA, 12…
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 0508.012Model Kenda Polishers
by Dent4You AG
Identity
- Trade Name
- KENDA Complete Pre-Polishers for Composite/Compomer/Gold/Amalgam, Point, RA, 12pcs EUDAMEDKENDA FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- KENDA Complete Pre-Polishers for Composite/Compomer/Gold/Amalgam, Point, RA, 12pcs FDA UDI
- Model / Reference
- Kenda Polishers EUDAMED0508.012 EUDAMEDFDA UDI
- Description
- KENDA Complete Pre-Polishers for Composite/Compomer/Gold/Amalgam, Point, RA, 12pcs FDA UDI
Identifiers
- Catalog Number
- 0508.012 FDA UDI
- Primary DI / UDI-DI
- 07630243641789 EUDAMEDFDA UDI
- Basic UDI-DI
- 76303929ROTA20031CV EUDAMED
- FDA Product Code
- EJQ FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
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
KENDA Complete Pre-Polishers for Composite/Compomer/Gold/Amalgam, Point, RA, 12… by Dent4You AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 76303929ROTA20031CV | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Dent4You AG
- EUDAMED SRN
- CH-MF-000028926
- Authorised Representative
- Dent4you GmbH DE-AR-000006093
Sources (2)
- EUDAMED 6c0a843e-5b0f-455e-ad58-09e20b4e1897 61 fields · synced Aug 1, 2026
- FDA UDI e2cda2ca-2b8f-449f-9b51-55d7048a6a05 34 fields · synced May 30, 2026