Skip to content

major.base 20 STANDARD-SET I

by Major Prodotti Dentari SpA EUDAMEDGUDID

Active European Union

Ref C3021-IModel Heat-polymerizable denture base polymer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08056640080751 UDI-DIDate30 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8056640B20AP Basic UDI-DIDate16 Mar 2026RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

1 certificate · EUDAMED

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

    Quality management system EU MDR

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Major.base 20 Stand.set I(2X500G+500ML) 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-I, STANDARD-SET I
Primary DI / UDI-DI
08056640080751
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-I
GUDID
STANDARD-SET I
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K081884)

Other devices from Major Prodotti Dentari SpA

See all devices from Major Prodotti Dentari SpA →

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