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MAJOR PLUS COMP V X6 LOWER D4-L1 Shade D4, Mould L1

by Major Prodotti Dentari SpA

Ref T2031.D4.L1.LModel Multilayer composite and 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 Number8056640CMPF8 Basic UDI-DI 08056640001954UDI-DIDate16 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08056640001954 UDI-DI Date17 Jul 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  • Withdrawn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 Plus Comp V X6 Lower D4-L1
Generic Name
Resin artificial teeth
Device Name
Major Plus Comp, AF Comp
Model / Ref / Catalog
Multilayer composite and acrylic resin artificial teeth EUDAMED
T2031.D4.L1.L EUDAMED
Shade D4 GUDID
Mould L1 GUDID
T2031 GUDID
Description
MAJOR PLUS COMP V , SIX ARTIFICIAL TEETH, LOWER, SHADE D4, MOULD L1
Primary DI / UDI-DI
08056640001954
Basic UDI-DI
8056640CMPF8
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
Multilayer composite and acrylic resin artificial teeth
T2031.D4.L1.L
GUDID
Shade D4, Mould L1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Resin artificial teeth

Other devices from Major Prodotti Dentari SpA

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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