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Cal LC Trial Pack

by Prevest Denpro Limited

Ref 30004Model Sealant, Liner and Base material

Cal LC Trial Pack (30004) is a device classified as Class IIa in the EU and Class II in the US made by Prevest Denpro Limited, registered in EUDAMED on 6 Aug 2026 (Basic UDI-DI B-+D967300040/), cleared under FDA 510(k) K212475 on 13 May 2022 and listed in FDA GUDID since 8 Dec 2022 (UDI-DI +D967300040/), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K212475

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+D967300040/ Basic UDI-DI +D967300040/UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+D967300040/ UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK212475 Date13 May 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-+D967300040/ registered 6 Aug 2026 Active
  • FDA 510(k) K212475 decided 13 May 2022 Active
  • FDA GUDID UDI-DI +D967300040/ listed 8 Dec 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K212475
  2. Listed FDA GUDID +D967300040/
  3. Registered EUDAMED B-+D967300040/

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  • Withdrawn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
Cal LC
Generic name
Calcium hydroxide dental cement
Model / Ref / Catalog
Sealant, Liner and Base material, 30004, Trial Pack
Primary DI / UDI-DI
+D967300040/ EUDAMED
D967300040 GUDID
Basic UDI-DI
B-+D967300040/
510(k) Number
FDA product code
EJK
EMDN code
Q01010199 Dental restoration devices - other
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
Estonia
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Sealant, Liner and Base material
30004
GUDID
Trial Pack
Primary DI / UDI-DIEUDAMED
+D967300040/
GUDID
D967300040
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +D967300040/; FDA GUDID lists D967300040), so their flags are not compared. 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

Cleared under the same submission (K212475)

and 8 more cleared under K212475

Similar devices in this category

Other devices filed under DENTAL RESTORATION DEVICES - OTHER.

Other devices from Prevest Denpro Limited

See all devices from Prevest Denpro Limited →

Properties

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