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DENTOCORE Cartridge white shade

by Itena Clinical

Ref DCB-50

DENTOCORE Cartridge white shade (DCB-50) is a dental composite resin (EU MDD Class IIa; FDA Class II; FDA product code EBF, Material, Tooth Shade, Resin) made by Itena Clinical, registered in EUDAMED on 26 May 2026 (Basic UDI-DI B-03760260222037), cleared under FDA 510(k) K121769 on 5 Mar 2013 and listed in FDA GUDID since 15 Oct 2016 (UDI-DI 03760260222037), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K121769

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760260222037 Basic UDI-DI 03760260222037UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760260222037 UDI-DI Date15 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK121769 Date5 Mar 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03760260222037 registered 26 May 2026 Active
  • FDA 510(k) K121769 decided 5 Mar 2013 Active
  • FDA GUDID UDI-DI 03760260222037 listed 15 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K121769
  2. Listed FDA GUDID 03760260222037
  3. Registered EUDAMED B-03760260222037

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  • Withdrawn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
Dentocore
Generic name
Dental composite resin
Model / Ref / Catalog
DCB-50, Cartridge white shade
Primary DI / UDI-DI
03760260222037
Basic UDI-DI
B-03760260222037
510(k) Number
FDA product code
EBF
EMDN code
Q01010199 Dental restoration devices - other
GMDN term
Dental composite resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 4 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
DCB-50
GUDID
Cartridge white shade
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No
Contains latexEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Contains latex UDI-DI 03760260222037: EUDAMED states Yes, FDA GUDID states 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 composite resin

Cleared under the same submission (K121769)

Similar devices in this category

Other devices filed under DENTAL RESTORATION DEVICES - OTHER.

Other devices from Itena Clinical

See all devices from Itena Clinical →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Contains latex YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)