Identity
- Trade Name
- Tetric N-Color 2 Refill 1x1g Ochre EUDAMED
- Device Name
- IPS Empress Direct Effect, IPS Empress Direct Color, IPS Empress Direct Opaque, Tetric N-Effect 2, Tetric N-Color 2, Tetric N-Opaque 2 EUDAMED
- Model / Reference
- 765186AN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07615208525854 EUDAMED
- Basic UDI-DI
- 76152082AFILL015JM EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Liechtenstein EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
Category: Dental composite resin
Tetric N-Color 2 Refill 1x1g Ochre by Ivoclar Vivadent AG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 76152082AFILL015JM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent AG
- EUDAMED SRN
- LI-MF-000000522
Sources (1)
- EUDAMED 1086f32d-611b-4280-a070-3e658ad038f0 61 fields · synced Aug 1, 2026