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Vita Enamic®

by VITA Zahnfabrik H. Rauter GmbH & Co. KG 178 variants

Ref ECDEM4981828, EC4EMSTSETT, EN1EM3202765, EK0M1HTEM14, EPMEM4022765, EN1EC4202765, EA0EC4282765, EPMEC4072765, EPMEM3122765P, EA0EC4122765A, EC4EC4202765, EC4EM3112765, EC4EC4282885, EN1EM3022765, ECDEM4981207, ECDEM3981220, EN1EM4022645, ECDEM3981207, EKEMSTSETTK

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++J017CC0PU Basic UDI-DI Date8 Jul 2024RegisteredStatusActive
United StatesGUDID listing GUDID NumberJ017ECDEM49818280 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 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  • Withdrawn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, ceramic
Device Name
Machinable Ceramic
Model / Reference
ECDEM4981828, EC4EMSTSETT, EN1EM3202765, EA0EC4282765, EPMEM3122765P, EC4EC4202765, EC4EC4282885, EPMEC4072765, EPMEM4022765, ECDEM4981207, EN1EM4022645, EA0EC4122765A, ECDEM3981220, ECDEM3981207, EC4EM3112765, EK0M1HTEM14, EN1EM3022765, EN1EC4202765, EKEMSTSETTK
Primary DI / UDI-DI
J017ECDEM49818280, J017EC4EMSTSETT0, J017EN1EM32027650, J017EA0EC42827650, J017EPMEM3122765P0, J017EC4EC42027650, J017EC4EC42828850, J017EPMEC40727650, J017EPMEM40227650, J017ECDEM49812070, J017EN1EM40226450, J017EA0EC4122765A0, J017ECDEM39812200, J017ECDEM39812070, J017EC4EM31127650, J017EK0M1HTEM140, J017EN1EM30227650, J017EN1EC42027650, J017EKEMSTSETTK0
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

Manufacturer details

EUDAMED SRN
DE-MF-000005906

Other devices from VITA Zahnfabrik H. Rauter GmbH & Co. KG

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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