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Ruthinium Disc

by Dental Manufacturing SpA

Ref 7900087

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

CE MDR

Valid until

5 Aug 2031

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

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
United StatesGUDID listing GUDID Number08056865790879 UDI-DI Date17 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number805686501AAPR50AN Basic UDI-DI 08056865790879UDI-DIDate3 Sep 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030211-00 Active

    Quality management system EU MDR

    Certifier
    ICIM S.P.A. 0425
    Issued
    6 Aug 2026
    Expires
    5 Aug 2031

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 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  • Withdrawn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

Generic Name
Dental appliance fabrication material, resin
Model / Ref / Catalog
7900087, RUTHINIUM DISC
Primary DI / UDI-DI
08056865790879
Basic UDI-DI
805686501AAPR50AN
Direct Marketing DI
08056865790879
510(k) Number
FDA Product Code
POW, EBG
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
872.3770
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
7900087
GUDID
RUTHINIUM DISC
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K261456)

Other devices from Dental Manufacturing SpA

See all devices from Dental Manufacturing SpA →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • Expiration Date: No
  • Manufacturing Date: No