Identity
- Trade Name
- ProBase Cold Monomer 500 ml EUDAMEDProBase Hot / ProBase Cold FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- ProBase Hot / ProBase Cold, SR Triplex Cold EUDAMEDProBase Cold Monomer 500 ml FDA UDI
- Model / Reference
- 531505 EUDAMEDFDA UDI
- Description
- ProBase Cold Monomer 500 ml FDA UDI
Identifiers
- Catalog Number
- 531505 FDA UDI
- Primary DI / UDI-DI
- 07615208006117 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152082APROS001VT EUDAMED
- FDA Product Code
- EBI FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3760 FDA UDI
- Market of Registration
- Liechtenstein EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Dental appliance fabrication material, resin
ProBase Hot / ProBase Cold by Ivoclar Vivadent Aktiengesellschaft — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent Aktiengesellschaft
Sources (2)
- FDA UDI e4ad309e-c57e-4f8b-aa0b-ebcdb240f342 34 fields · synced Oct 6, 2026
- EUDAMED 2709d5a9-016a-4172-889b-9a57daf24201 61 fields · synced Jul 30, 2026