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Vita Enamic EGLEM4122765

by Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft

Ref EGLEM4122765

Withdrawn Withdrawn in European Union.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

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
European UnionCE/MDR EUDAMED Number++J017CC0PU Basic UDI-DI J017EGLEM41227650UDI-DIDate8 Jul 2024RegisteredStatusWithdrawn
United StatesGUDID listing GUDID NumberJ017EGLEM41227650 UDI-DI Date18 Feb 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.

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  • Withdrawn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  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Vita Enamic® EUDAMED
Vita Enamic GUDID
Generic Name
Dental appliance fabrication material, ceramic
Device Name
Machinable Ceramic
Model / Reference
EGLEM4122765
Primary DI / UDI-DI
J017EGLEM41227650
Basic UDI-DI
++J017CC0PU
510(k) Number
FDA Product Code
EIH
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN Term
Dental appliance fabrication material, ceramic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.6660
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

Related devices

Category: Dental appliance fabrication material, ceramic

Cleared under the same submission (K122269)

Other devices from Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft

See all devices from Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • 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