Identity
- Trade Name
- ANAXDENT PMMA BLANK FDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- ANAXDENT PMMA MULTI BLANK AG A2 20mm FDA UDI
- Model / Reference
- PMMA MULTI Blank AG A2 20mm FDA UDI
- Description
- ANAXDENT PMMA MULTI BLANK AG A2 20mm FDA UDI
Identifiers
- Catalog Number
- 18221220 FDA UDI
- Primary DI / UDI-DI
- 08435288418193 FDA UDI
- 510(k) Number
- K150432 FDA UDI
- FDA Product Code
- EBI FDA UDIEBG FDA UDI
- GMDN Term
- Temporary dental crown/bridge FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 FDA UDI872.3770 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Anaxdent Pmma Blank by Union Dental Sa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K150432 also covers:
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
- Union Dental Sa
Sources (1)
- FDA UDI 9187a2dd-32d4-4a1b-a564-4acdae0bc933 36 fields · synced Jun 1, 2026