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ParaCore Dentin 5x5ml

by Dent4You AG

Part of a family of 8 devices: see the family page

Ref 60036588Model ParaCore

ParaCore Dentin 5x5ml (60036588) is a device classified as Class IIa in the EU and Class II in the US made by Dent4You AG, registered in EUDAMED on 8 May 2026 (Basic UDI-DI 76303929COMP201114F), cleared under FDA 510(k) K052820 on 9 Jan 2006 and listed in FDA GUDID since 7 Jul 2026 (UDI-DI 07630243634750), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K052820

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07630243634750 UDI-DI Date7 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number76303929COMP201114F Basic UDI-DI 07630243634750UDI-DIDate8 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK052820 Date9 Jan 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 76303929COMP201114F registered 8 May 2026 Active
  • FDA 510(k) K052820 decided 9 Jan 2006 Active
  • FDA GUDID UDI-DI 07630243634750 listed 7 Jul 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K052820
  2. Registered EUDAMED 76303929COMP201114F
  3. Listed FDA GUDID 07630243634750

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  • Withdrawn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
ParaCore Dentin 5x5ml EUDAMED
ParaCore GUDID
Generic name
Dental veneer, professional
Model / Ref / Catalog
ParaCore, 60036588
Primary DI / UDI-DI
07630243634750
Basic UDI-DI
76303929COMP201114F
510(k) Number
FDA product code
EBF
EMDN code
Q01010103 Dental restorative composites
GMDN term
Dental veneer, professional
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690
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.

Manufacturer details

EUDAMED SRN
CH-MF-000028926
Authorised representative
Coltène/Whaledent GmbH + Co. KG DE-AR-000005719

Similar devices in this category

Other devices filed under DENTAL RESTORATIVE COMPOSITES.

Other devices from Dent4You AG

See all devices from Dent4You AG →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)