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Major.base 20 - Standard Set IV

by Major Prodotti Dentari S.p.A.

Ref C3021-IVModel Heat-polymerizable denture base polymer

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

CE MDR

Valid until

18 Apr 2029

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier ICIM S.P.A.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08056640078321 UDI-DI Date30 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8056640B20AP Basic UDI-DI 08056640078321UDI-DIDate16 Mar 2026RegisteredStatusActive

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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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.base 20 - Standard Set IV EUDAMED
major.base 20 GUDID
Generic Name
Dental appliance fabrication material, resin
Device Name
MAJOR.BASE.20
Model / Ref / Catalog
Heat-polymerizable denture base polymer, C3021-IV, STANDARD-SET IV
Primary DI / UDI-DI
08056640078321
Basic UDI-DI
8056640B20AP
510(k) Number
FDA Product Code
EBI
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN Term
Dental appliance fabrication material, resin
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3760
Market of Registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Heat-polymerizable denture base polymer
C3021-IV
GUDID
STANDARD-SET IV
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
IT-MF-000024700

Other devices from Major Prodotti Dentari S.P.A.

See all devices from Major Prodotti Dentari S.P.A. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No