Identity
- Trade Name
- ProBase Hot / ProBase Cold FDA UDI
- Generic Name
- Denture base resin kit FDA UDI
- Device Name
- ProBase Hot Lab Kit US-L FDA UDI
- Model / Reference
- 531795AN FDA UDI
- Description
- ProBase Hot Lab Kit US-L FDA UDI
Identifiers
- Catalog Number
- 531795AN FDA UDI
- Primary DI / UDI-DI
- 07615208302776 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Denture base resin kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Denture base resin kit
ProBase Hot / ProBase Cold by Ivoclar Vivadent Aktiengesellschaft — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Dentorium — Wright Health Group , Ltd. · Class II
- Dentorium — Wright Health Group , Ltd. · Class II
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
- Ivoclar Vivadent Aktiengesellschaft
Sources (1)
- FDA UDI 99faeff1-202b-4103-8ae7-38a34136086e 34 fields · synced Jun 7, 2026