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Dental Zirconia Ceramic Block

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

Ref Multilayer-3DProModel 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. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06977209715001 UDI-DI Date11 Mar 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697480490002LT Basic UDI-DI 06977209715001UDI-DIDate28 Apr 2025RegisteredStatusActive

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  • Withdrawn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
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Dental appliance fabrication material, ceramic
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, Multilayer-3DPro
Primary DI / UDI-DI
06977209715001 EUDAMED
06977209717883 GUDID
Basic UDI-DI
697480490002LT
510(k) Number
FDA Product Code
EIH
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN Term
Dental appliance fabrication material, ceramic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.6660
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06977209715001
GUDID
06977209717883
Device ClassEUDAMED
Class IIa
GUDID
Class II

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

  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No