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Zirconia Block

by Shandong Huge Dental Material Corporation 9 variants

Ref MaxMultilayer-4D(MM-4D)/98×16mm/B1/1*1Model High Translucency (HT), Anterior Translucency (AT), High Strength (HS), Multi-layered High Translucency (MHT), High Translucency Plus (HT PLUS), Gradient Multilayer (GM), MaxMultilayer-4D (MM-4D), Anterior Translucency Multilayer (ATML)

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
United StatesGUDID listing GUDID Number06909412231597 UDI-DI Date26 Oct 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number6909412YHG2A01XN Basic UDI-DI 06909412231597UDI-DIDate26 May 2025RegisteredStatusActive

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  • Withdrawn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

Generic Name
Dental appliance fabrication material, ceramic
Model / Ref / Catalog
High Translucency (HT) EUDAMED
Anterior Translucency (AT) EUDAMED
High Strength (HS) EUDAMED
Multi-layered High Translucency (MHT) EUDAMED
High Translucency Plus (HT PLUS) EUDAMED
Gradient Multilayer (GM) EUDAMED
MaxMultilayer-4D (MM-4D) EUDAMED
Anterior Translucency Multilayer (ATML) EUDAMED
MaxMultilayer-4D(MM-4D)/98×16mm/B1/1*1 EUDAMED
MM-4D GUDID
98×16mm/B1/1×1/Blue GUDID
Primary DI / UDI-DI
06909412231597
Basic UDI-DI
6909412YHG2A01XN
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
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-000013266
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Shandong Huge Dental Material Corporation

See all devices from Shandong Huge Dental Material Corporation →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No