Skip to content

Kera-Disc

by Eisenbacher Dentalwaren ED GmbH

Ref D10041208Model NPM Cobalt-based dental milling alloy for metal-ceramic, type 4

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++EDWACADCAMNEMQH Basic UDI-DI EDWAD100412081UDI-DIDate24 Jul 2024RegisteredStatusActive
United StatesGUDID listing GUDID NumberEDWAD100412081 UDI-DI Date11 Jul 2017ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Kera-Disc EUDAMED
Kera-Disc 98,3 x 8 mm GUDID
Generic Name
Dental casting non-noble alloy
Model / Reference
NPM Cobalt-based dental milling alloy for metal-ceramic, type 4, D10041208
Primary DI / UDI-DI
EDWAD100412081
Basic UDI-DI
++EDWACADCAMNEMQH
FDA Product Code
EJH
EMDN Code
Q010601 Dental alloys
GMDN Term
Dental casting non-noble alloy
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3710
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000008322

Related devices

Category: Dental casting non-noble alloy

Other devices from Eisenbacher Dentalwaren Ed GmbH

See all devices from Eisenbacher Dentalwaren Ed GmbH →

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