Identity
- Trade Name
- IvoBase Hybrid Kit 20 Clear EUDAMEDIvoBase HI / IvoBase Hybrid 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 EUDAMEDIvoBase Hybrid Kit 20 Clear FDA UDI
- Model / Reference
- 628888AN EUDAMEDFDA UDI
- Description
- IvoBase Hybrid Kit 20 Clear FDA UDI
Identifiers
- Catalog Number
- 628888AN FDA UDI
- Primary DI / UDI-DI
- 07615208297461 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
IvoBase HI / IvoBase Hybrid 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 e94d8036-c309-4659-a4e3-0ec7e5d9a8fa 34 fields · synced Aug 4, 2026
- EUDAMED 4d7d32c8-5d2b-4fc4-be8f-1250f9ccdf59 61 fields · synced Aug 4, 2026