Identity
- Trade Name
- UNIMETRIC 0.8 MM Special calibration drill FDA UDI
- Generic Name
- Pin/post dental drill bit FDA UDI
- Device Name
- Endodontic Posts Drills FDA UDI
- Model / Reference
- C021320000800 FDA UDI
- Description
- Endodontic Posts Drills FDA UDI
Identifiers
- Catalog Number
- C021320000800 FDA UDI
- Primary DI / UDI-DI
- J003C0213200008001 FDA UDI
- FDA Product Code
- DZA FDA UDI
- GMDN Term
- Pin/post dental drill bit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4130 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
UNIMETRIC 0.8 MM Special calibration drill by Maillefer Instruments Holding Sàrl — 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
- Maillefer Instruments Holding Sàrl
Sources (1)
- FDA UDI e7d4f54d-c5c8-488e-95b3-7d44e5367901 36 fields · synced Jun 9, 2026