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Porcelain Powders K-002-17

by Shandong Huge Dental Material Corporation EUDAMEDGUDID

Active European Union

Ref Blending Liquid/20mL*1, Stain/Glaze/5g*17; AccessoriesModel Powder; Blending Liquid; Stain/Glaze

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6909412KCF2A01MU Basic UDI-DIDate28 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06909412344334 UDI-DIDate19 May 2026ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Porcelain Powders
Generic Name
Dental porcelain/ceramic restoration kit
Model / Ref / Catalog
Powder EUDAMED
Blending Liquid EUDAMED
Stain/Glaze EUDAMED
Blending Liquid/20mL*1 EUDAMED
Stain/Glaze/5g*17 EUDAMED
Accessories EUDAMED
/ GUDID
K-002-17 GUDID
Primary DI / UDI-DI
06909412344334
Basic UDI-DI
6909412KCF2A01MU
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
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Powder; Blending Liquid; Stain/Glaze
Blending Liquid/20mL*1, Stain/Glaze/5g*17; Accessories
GUDID
/
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K260067)

Other devices from Shandong Huge Dental Material Corporation

See all devices from Shandong Huge Dental Material Corporation →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration 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
  • Manufacturing Date: No