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Tetric N-Color 2 Refill 1x1g White

by Ivoclar Vivadent AG

Ref 765185AN

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number76152082AFILL015JM Basic UDI-DI 07615208525540UDI-DIDate10 Feb 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

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
Model / Reference
765185AN
Primary DI / UDI-DI
07615208525540
Basic UDI-DI
76152082AFILL015JM
EMDN Code
Q01010103 Dental restorative composites
Device Class
Class IIa
EU market of registration
Liechtenstein

Manufacturer details

EUDAMED SRN
LI-MF-000000522

Related devices

Category: Dental composite resin

Other devices from Ivoclar Vivadent AG

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Properties

  • Implantable

Other properties (12)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No