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Zirconia Dental Ceramics

by De Corematrix Co., Ltd EUDAMEDGUDID

Active European Union

Ref 3DML 98D18 D4

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06974208588582 UDI-DIDate29 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697802123DECMEDZ Basic UDI-DIDate7 Apr 2026RegisteredStatusActive

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
DE corematrix
Generic Name
Dental porcelain/ceramic restoration kit
Device Name
Zirconia Dental Ceramics
Model / Reference
3DML 98D18 D4 EUDAMED
CMC/CMW GUDID
Primary DI / UDI-DI
06974208588582
Basic UDI-DI
697802123DECMEDZ
510(k) Number
FDA Product Code
EIH
EMDN Code
Q01010199 Dental restoration devices - other
GMDN Term
Dental porcelain/ceramic restoration kit
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.6660
Market of Registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
3DML 98D18 D4
GUDID
CMC/CMW
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000025755
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from De Corematrix Co., Ltd.

See all devices from De Corematrix Co., Ltd. →

Properties

  • Single Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Expiration Date: No