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Ionoseal 1326

by VOCO GmbH

Ref 1326

Ionoseal 1326 is a device classified as Class IIa in the EU and Class II in the US made by VOCO GmbH, registered in EUDAMED on 30 Mar 2026 (Basic UDI-DI ++E2210660000000000ER) and listed in FDA GUDID since 31 Aug 2016 (UDI-DI E22113261), active as of 22 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E2210660000000000ER Basic UDI-DI E22113261UDI-DIDate30 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE22113261 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++E2210660000000000ER registered 30 Mar 2026 Active
  • FDA GUDID UDI-DI E22113261 listed 31 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID E22113261
  2. Registered EUDAMED ++E2210660000000000ER

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  • Withdrawn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
Ionoseal
Generic name
Glass ionomer dental cement
Model / Ref / Catalog
1326
Primary DI / UDI-DI
E22113261
Basic UDI-DI
++E2210660000000000ER
FDA product code
EJK
EMDN code
Q0101010201 Dental base cements
GMDN term
Glass ionomer dental cement
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3250
EU registration type
Standard device
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.

Similar devices in this category

Other devices filed under DENTAL BASE CEMENTS.

Other devices from VOCO GmbH

See all devices from VOCO GmbH →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)