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CERABIEN MiLai Internal Stain A+ (3g)

by Kuraray Noritake Dental Inc. Miyoshi

Ref 109-0481EUModel PORCELAIN

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250673↗

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04571215134003 Basic UDI-DI 04571215134003UDI-DIDate19 Dec 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK250673 Date29 May 2025IssuedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k)

Model / Reference
PORCELAIN, 109-0481EU
Primary DI / UDI-DI
04571215134003
Basic UDI-DI
B-04571215134003
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000017328
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

  • Implantable

Other properties (10)

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