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Calcimol 1097

by VOCO GmbH

Ref 1097Model tube

Calcimol 1097 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-E22110971) and listed in FDA GUDID since 31 Aug 2016 (UDI-DI E22110971), active as of 22 Oct 2026.

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

CE MDD

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/MDD EUDAMED NumberB-E22110971 Basic UDI-DI E22110971UDI-DIDate20 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE22110971 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-E22110971 registered 20 Apr 2026 Active
  • FDA GUDID UDI-DI E22110971 listed 31 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID E22110971
  2. Registered EUDAMED B-E22110971

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Calcimol
Generic name
Calcium hydroxide dental cement
Model / Ref / Catalog
1097, tube
Primary DI / UDI-DI
E22110971
Basic UDI-DI
B-E22110971
FDA product code
EJK
EMDN code
Q01010201 Root canal filling dental pastes
GMDN term
Calcium hydroxide dental cement
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3250
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.

Similar devices in this category

Other devices filed under ROOT CANAL FILLING DENTAL PASTES.

Other devices from VOCO GmbH

See all devices from VOCO GmbH →

Properties

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