Identity
- Trade Name
- Alpen FDA UDI
- Generic Name
- Carbide dental bur, reusable FDA UDI
- Device Name
- U SU DMD FLT END TPR 848 16 SC FDA UDI
- Model / Reference
- XU848SC016 FDA UDI
- Description
- U SU DMD FLT END TPR 848 16 SC FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661XU848SC0161 FDA UDI
- FDA Product Code
- EJL FDA UDI
- GMDN Term
- Carbide dental bur, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3240 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Alpen by Coltene/Whaledent Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Coltene/Whaledent Inc.
Sources (1)
- FDA UDI eb888558-5826-42b8-aa90-9a7b49173ea5 34 fields · synced Jun 9, 2026