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Calcimol LC 1307

by VOCO GmbH

Ref 1307

Calcimol LC 1307 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 ++E2210640000000000CT), cleared under FDA 510(k) K924182 on 16 Oct 1992 and listed in FDA GUDID since 31 Aug 2016 (UDI-DI E22113071), active as of 25 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K924182

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E2210640000000000CT Basic UDI-DI E22113071UDI-DIDate30 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE22113071 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK924182 Date16 Oct 1992IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++E2210640000000000CT registered 30 Mar 2026 Active
  • FDA 510(k) K924182 decided 16 Oct 1992 Active
  • FDA GUDID UDI-DI E22113071 listed 31 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K924182
  2. Listed FDA GUDID E22113071
  3. Registered EUDAMED ++E2210640000000000CT

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Calcimol LC
Generic name
Calcium hydroxide dental cement
Model / Ref / Catalog
1307
Primary DI / UDI-DI
E22113071
Basic UDI-DI
++E2210640000000000CT
510(k) Number
FDA product code
EJK
EMDN code
Q0101010201 Dental base cements
GMDN term
Calcium hydroxide 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.

Related devices

Category: Calcium hydroxide dental cement

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)