Identity
- Trade Name
- Ivostar Set of 6 U34 2E EUDAMED
- Device Name
- Ivostar / Gnathostar, Ivocryl, Resin Teeth / DCL / PE, Resin Teeth S PE / S DCL, SR Phonares II EUDAMED
- Model / Reference
- 517373 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07615208425062 EUDAMED
- Basic UDI-DI
- 76152082APROS004VZ EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Liechtenstein EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Ivostar Set of 6 U34 2E by Ivoclar Vivadent AG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76152082APROS004VZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent AG
- EUDAMED SRN
- LI-MF-000000522
Sources (1)
- EUDAMED cbc76a71-dbcc-45f7-ba41-ba6ca605c0e6 61 fields · synced Oct 6, 2026