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Dental Zirconia Block

by Shenzhen Yurucheng Dental Materials Co., Ltd. 1,000+ variants

Ref 16187Model Color 0M1-HT 89×71×22

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06974242688767 UDI-DI Date7 Aug 2023ListedStatusListed GUDID: not in commercial distribution
European UnionCE/MDD EUDAMED NumberB-06974242688767 Basic UDI-DI 06974242688767UDI-DIDate12 Jul 2023RegisteredStatusActive

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 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Dental Zirconia Block EUDAMED
Yucera GUDID
Generic Name
Dental appliance fabrication material, ceramic
Device Name
Zirconia Dental Ceramics
Model / Ref / Catalog
Color 0M1-HT 89×71×22 EUDAMED
16187 EUDAMED
0M2 GUDID
HT 98×14mm GUDID
Primary DI / UDI-DI
06974242688767
Basic UDI-DI
B-06974242688767
510(k) Number
FDA Product Code
PKJ
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
N GUDID
EU market of registration
Türkiye
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Color 0M1-HT 89×71×22
16187
GUDID
0M2
Device ClassEUDAMED
Class IIa
GUDID
N
ImplantableEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
CN-MF-000011505
Authorised representative
Share Info Consultant Service LLC Repräsentanzbüro DE-AR-000005133

Other devices from Shenzhen Yurucheng Dental Materials Co., Ltd.

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Properties

  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

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