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Zirconia ceramic blocks for all ceramic dentures

by Hunan Ceramaster Material Technology Co., Ltd 8 variants

Ref Pro-MLModel SHT-ML,UT-C,UT-ML,Pro-ML,HT-plus,ST-C,ST-ML,SHT-C

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

CE MDR

Valid until

17 Jun 2031

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberCN26/00004557 Date17 Jun 2026IssuedStatusActive expires 17 Jun 2031
United StatesGUDID listing GUDID Number06976581410078 UDI-DI Date6 Jun 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN26/00004557 Active

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    17 Jun 2026
    Expires
    17 Jun 2031

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 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  • Withdrawn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

Trade Name
Zirconia ceramic blocks for all ceramic dentures EUDAMED
Dental Zirconia Blank GUDID
Generic Name
Dental appliance fabrication material, combination-material
Model / Reference
SHT-ML, UT-C, UT-ML, Pro-ML, HT-plus, ST-C, ST-ML, SHT-C
Primary DI / UDI-DI
06976581410078
Basic UDI-DI
697658141001MX
Direct Marketing DI
06976581410078
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, combination-material
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.6660
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
CN-MF-000036784
Authorised representative
Eunitor GmbH DE-AR-000005081

Other devices from Hunan Ceramaster Material Technology Co., Ltd

See all devices from Hunan Ceramaster Material Technology Co., Ltd →

Properties

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

Other properties (18)

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