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Polishette Diamond Polishers for Composites & Hybrid-Ceramics, Single-Use, F, M…
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PS716F.015Model Kenda Polishers Polishette
by Dent4You AG
Identity
- Trade Name
- Polishette Diamond Polishers for Composites & Hybrid-Ceramics, Single-Use, F, MiniPoint, RA, 15pcs EUDAMEDKENDA FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- Polishette Diamond Polishers for Composites & Hybrid-Ceramics, Single-Use, F, MiniPoint, RA, 15pcs FDA UDI
- Model / Reference
- Kenda Polishers Polishette EUDAMEDPS716F.015 EUDAMEDFDA UDI
- Description
- Polishette Diamond Polishers for Composites & Hybrid-Ceramics, Single-Use, F, MiniPoint, RA, 15pcs FDA UDI
Identifiers
- Catalog Number
- PS716F.015 FDA UDI
- Primary DI / UDI-DI
- 07630243645954 EUDAMEDFDA UDI
- Basic UDI-DI
- 76303929ROTA20032CX 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
Yes
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
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
Polishette Diamond Polishers for Composites & Hybrid-Ceramics, Single-Use, F, M… 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 | 76303929ROTA20032CX | 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 4e11839d-26dc-49f1-9cb8-3ac73f2ad3c7 61 fields · synced Jul 18, 2026
- FDA UDI 8eef2e4e-8b30-484f-9f07-e5ca5b061735 34 fields · synced May 29, 2026