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SUPER LUX A1-D4 X6 UPPER C1-1/32 Shade C1, Mould 1/32

by Major Prodotti Dentari SpA

Ref T3011.C1.1/32.UModel Acrylic resin artificial teeth

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

CE MDR

Valid until

18 Apr 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier ICIM S.P.A.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8056640TEEGF Basic UDI-DI 08056640031722UDI-DIDate5 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08056640031722 UDI-DI Date12 Sep 2019ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030075-01 Active

    Quality management system EU MDR

    Certifier
    ICIM S.P.A. 0425
    Issued
    12 May 2025
    Expires
    18 Apr 2029

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  • Withdrawn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
Major Super Lux A1-D4 X6 Upper C1-1/32 EUDAMED
Super Lux A1-D4 X6 Upper C1-1/32 GUDID
Generic Name
Resin artificial teeth
Device Name
Major Plus, Major Super Lux, Major Dent, Bambino tooth
Model / Ref / Catalog
Acrylic resin artificial teeth EUDAMED
T3011.C1.1/32.U EUDAMED
Shade C1 GUDID
Mould 1/32 GUDID
T3011 GUDID
Description
SUPER LUX A1-D4 , SIX ARTIFICIAL TEETH, UPPER, SHADE C1, MOULD 1/32
Primary DI / UDI-DI
08056640031722
Basic UDI-DI
8056640TEEGF
FDA Product Code
ELM
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN Term
Resin artificial teeth
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3590
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Acrylic resin artificial teeth
T3011.C1.1/32.U
GUDID
Shade C1, Mould 1/32
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Resin artificial teeth

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Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number

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