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Dental Zirconia Ceramics

by Liaoning Upcera Co Ltd 1,000+ variants

Ref /Model Dental Zirconia Pre-shaded Blank

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number694138229985JB Basic UDI-DI 06970596165909UDI-DIDate24 Oct 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number06970596165909 UDI-DI Date10 Jan 2017ListedStatusListed GUDID: in commercial distribution

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

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  • Withdrawn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

Trade Name
upcera Dental Zirconia Pre-Shaded Blank
Generic Name
Dental appliance fabrication material, ceramic
Device Name
Dental Zirconia Ceramics
Model / Reference
Dental Zirconia Pre-shaded Blank EUDAMED
/ EUDAMED
S-D4 D98-16 GUDID
Primary DI / UDI-DI
06970596165909
Basic UDI-DI
694138229985JB
Direct Marketing DI
06970596165909
FDA Product Code
EIH
EMDN Code
Q01010199 Dental restoration 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
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Dental Zirconia Pre-shaded Blank
/
GUDID
S-D4 D98-16
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000013088
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Related devices

Category: Dental appliance fabrication material, ceramic

Other devices from Liaoning Upcera Co., Ltd.

See all devices from Liaoning Upcera Co., Ltd. →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (20)

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