Identity
- Trade Name
- Gentle Hand-Bur Systems FDA UDI
- Generic Name
- Manual non-rotary dental instrument handle FDA UDI
- Device Name
- KC has been discontinued. FDA UDI
- Model / Reference
- KC FDA UDI
- Description
- KC has been discontinued. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860007700811 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Manual non-rotary dental instrument handle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Manual non-rotary dental instrument handle
Gentle Hand-Bur Systems by Dental Care For All International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dental Care For All International
Sources (1)
- FDA UDI a981b97d-43ae-4a46-af64-03de6d91d70d 33 fields · synced May 30, 2026