Identity
- Trade Name
- Burkhart 10:1 Temp C&B Material A2 76g FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Model / Reference
- 72720595 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854212006622 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3770 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Burkhart 10:1 Temp C&B Material A2 76g by Burkhart Dental Supply Co., The — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Burkhart Dental Supply Co., The
Sources (1)
- FDA UDI 0a7c2394-8282-4e98-8865-326165994345 34 fields · synced Jun 1, 2026