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Easy Glaze 1016

by VOCO GmbH

Ref 1016Model bottle

Easy Glaze 1016 is a device classified as Class IIa in the EU and Class II in the US made by VOCO GmbH, registered in EUDAMED on 20 Apr 2026 (Basic UDI-DI B-E22110161), cleared under FDA 510(k) K082285 on 24 Oct 2008 and listed in FDA GUDID since 5 Jun 2019 (UDI-DI E22110161), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K082285

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-E22110161 Basic UDI-DI E22110161UDI-DIDate20 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE22110161 UDI-DI Date5 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK082285 Date24 Oct 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-E22110161 registered 20 Apr 2026 Active
  • FDA 510(k) K082285 decided 24 Oct 2008 Active
  • FDA GUDID UDI-DI E22110161 listed 5 Jun 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K082285
  2. Listed FDA GUDID E22110161
  3. Registered EUDAMED B-E22110161

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Easy Glaze
Generic name
Dental restorative material varnish
Model / Ref / Catalog
1016, bottle
Primary DI / UDI-DI
E22110161
Basic UDI-DI
B-E22110161
510(k) Number
FDA product code
EBD
EMDN code
Q01010199, Q01020605
GMDN term
Dental restorative material varnish
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3310
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental restorative material varnish

Similar devices in this category

Other devices filed under DENTAL RESTORATION DEVICES - OTHER.

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Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)