Identity
- Trade Name
- Ivocryl Bouche à 8 A-D IUK28 B4 EUDAMED
- Device Name
- Ivostar / Gnathostar, Ivocryl, Resin Teeth / DCL / PE, Resin Teeth S PE / S DCL, SR Phonares II EUDAMED
- Model / Reference
- 630992 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07615208362497 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
Ivocryl Bouche à 8 A-D IUK28 B4 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ivoclar Vivadent AG
- EUDAMED SRN
- LI-MF-000000522
Sources (1)
- EUDAMED 2d98db2b-9314-4e9c-8973-3544e3bd94ab 61 fields · synced Aug 3, 2026