Identity
- Trade Name
- SR Ivocap High Impact Standard Kit US-P EUDAMEDSR Ivocap High Impact FDA UDI
- Generic Name
- Denture base resin kit FDA UDI
- Device Name
- IvoBase Hybrid, SR Ivocap High Impact, SR Ivocap Clear, SR Triplex Hot/SR Triplex Cold EUDAMEDSR Ivocap High Impact Standard Kit US-P FDA UDI
- Model / Reference
- 531403AN EUDAMEDFDA UDI
- Description
- SR Ivocap High Impact Standard Kit US-P FDA UDI
Identifiers
- Catalog Number
- 531403AN FDA UDI
- Primary DI / UDI-DI
- 07615208303032 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152082APROS009WB EUDAMED
- FDA Product Code
- EBI FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Denture base resin kit 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
SR Ivocap High Impact 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
European Union Unknown
MDR
United States Pending data
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 30105cf3-a058-4b43-b29b-f04dc4cb1daf 34 fields · synced Jun 19, 2026
- EUDAMED 02a553d7-22e2-4bff-96a8-7fac259a9746 61 fields · synced Jun 19, 2026