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Kenda
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 5100.012Model Kenda Polishers
by Dent4You AG
Identity
- Trade Name
- KENDA Prophy Polishers for Prophylaxis, Assortment, RA, 12pcs EUDAMEDKENDA FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- KENDA Prophy Polishers for Prophylaxis, Assortment, RA, 12pcs FDA UDI
- Model / Reference
- 5100.012 EUDAMEDFDA UDIKenda Polishers EUDAMED
- Description
- KENDA Prophy Polishers for Prophylaxis, Assortment, RA, 12pcs FDA UDI
Identifiers
- Catalog Number
- 5100.012 FDA UDI
- Primary DI / UDI-DI
- 07630243645411 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
Category: Dental abrasive point, reusable
Kenda by Dent4You AG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental abrasive point, reusable.
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- Strauss Diamond — Diamond Strauss Instruments Inc · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dent4You AG
Sources (2)
- FDA UDI 8721ce84-a7fa-4705-bee4-f78e5453435c 34 fields · synced Aug 3, 2026
- EUDAMED 9380ec60-2be5-4aff-9207-2d53a18ee072 61 fields · synced Aug 3, 2026