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SUPER LUX A1-D4 X8 LOWER A2-A32 Shade A2, Mould A32

by Major Prodotti Dentari SpA

Ref T3012.A2.A32.LModel 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8056640TEEGF Basic UDI-DI 08056640034457UDI-DIDate5 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08056640034457 UDI-DI Date8 Oct 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  • Withdrawn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 X8 Lower A2-A32 EUDAMED
Super Lux A1-D4 X8 Lower A2-A32 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
T3012.A2.A32.L EUDAMED
Shade A2 GUDID
Mould A32 GUDID
T3012 GUDID
Description
SUPER LUX A1-D4 , EIGHT ARTIFICIAL TEETH, LOWER, SHADE A2, MOULD A32
Primary DI / UDI-DI
08056640034457
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
T3012.A2.A32.L
GUDID
Shade A2, Mould A32
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