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Dental Zirconia Ceramic Block

by Yilink (Tianjin) Biotechnology Co., Ltd 6 variants

Ref ATModel HT ，SHT， SHTP， Color ，Multilayer ，Multi-mix ，Multilayer-SHT， Multilayer-SHTP， Multilayer-3D， Multilayer-3DPro， Multilayer-AT ，Color-SHTC ，Color-SHTP ，Color-AT AT

Active European Union and United States

CE MDR 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) K222520↗

FDA record

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/MDR EUDAMED Number697480490002LT Basic UDI-DI 06977209715056UDI-DIDate28 Apr 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK222520 Date14 Nov 2022IssuedStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED · 510(k)

Model / Reference
HT ，SHT， SHTP， Color ，Multilayer ，Multi-mix ，Multilayer-SHT， Multilayer-SHTP， Multilayer-3D， Multilayer-3DPro， Multilayer-AT ，Color-SHTC ，Color-SHTP ，Color-AT AT, AT
Primary DI / UDI-DI
06977209715056
Basic UDI-DI
697480490002LT
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
CN-MF-000035085
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Yilink (Tianjin) Biotechnology Co., Ltd

See all devices from Yilink (Tianjin) Biotechnology Co., Ltd →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: 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