Identity
- Trade Name
- Carbide Bur FDA UDI
- Generic Name
- Carbide dental bur, reusable FDA UDI
- Device Name
- CARBIDE DEBONDING BUR 12 FLUTES SAFE TAPER PK/5 DIAMETER 1.6 MM/HEADLENGTH 8.3 FDA UDI
- Model / Reference
- FGH22-016ALGK FDA UDI
- Description
- CARBIDE DEBONDING BUR 12 FLUTES SAFE TAPER PK/5 DIAMETER 1.6 MM/HEADLENGTH 8.3 FDA UDI
Identifiers
- Catalog Number
- FGH22-016ALGK FDA UDI
- Primary DI / UDI-DI
- 00190746059599 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
- 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
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
Category: Carbide dental bur, reusable
Carbide Bur by American Orthodontics — 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
- American Orthodontics
Sources (1)
- FDA UDI 8020dd86-cd56-4d6d-9120-9e52d6b40889 35 fields · synced Jun 9, 2026