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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 and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K141724↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number694138229985JB Basic UDI-DI 06941382203594UDI-DIDate24 Oct 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number06941382203594 UDI-DI Date21 Mar 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK141724 Date22 Oct 2014IssuedStatusActive

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  • Withdrawn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
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · 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
M-A1 40-19-15 GUDID
Primary DI / UDI-DI
06941382203594
Basic UDI-DI
694138229985JB
Direct Marketing DI
06941382203594
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
M-A1 40-19-15
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.

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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