Identity
- Trade Name
- TC cavity Burs Round FDA UDI
- Generic Name
- Carbide dental bur, reusable FDA UDI
- Device Name
- Dental burs FDA UDI
- Model / Reference
- E012324100500 FDA UDI
- Description
- Dental burs FDA UDI
Identifiers
- Catalog Number
- E012324100500 FDA UDI
- Primary DI / UDI-DI
- J003E0123241005001 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
TC cavity Burs Round 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 2ef77c23-9e78-49e8-9341-b199543431ce 36 fields · synced Jun 9, 2026