Identity
- Trade Name
- 21 Burnisher FDA UDI
- Generic Name
- Dental restoration carver, resin FDA UDI
- Model / Reference
- BBA21 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810060722060 FDA UDI
- FDA Product Code
- EKJ FDA UDI
- GMDN Term
- Dental restoration carver, resin FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
Moist Heat or Steam Sterilization FDA UDI
21 Burnisher by Berman Instruments LLC — 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
- Berman Instruments LLC
Sources (1)
- FDA UDI 5e51d4e8-ea26-448b-b2d2-e951fac75aa1 33 fields · synced May 30, 2026