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Core It Blue 101-0302

by Spident Co., Ltd.

Ref #2101BL

Core It Blue 101-0302 is a device classified as Class IIa in the EU and Class II in the US made by Spident Co., Ltd., registered in EUDAMED on 7 May 2026 (Basic UDI-DI B-08809262954845), cleared under FDA 510(k) K092572 on 26 Aug 2009 and listed in FDA GUDID since 20 Feb 2017 (UDI-DI 08809262954845), 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) K092572

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-08809262954845 Basic UDI-DI 08809262954845UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809262954845 UDI-DI Date20 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK092572 Date26 Aug 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08809262954845 registered 7 May 2026 Active
  • FDA 510(k) K092572 decided 26 Aug 2009 Active
  • FDA GUDID UDI-DI 08809262954845 listed 20 Feb 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K092572
  2. Listed FDA GUDID 08809262954845
  3. Registered EUDAMED B-08809262954845

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  • Withdrawn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
Core it dual blue EUDAMED
Core It Blue GUDID
Generic name
Dental composite resin
Device name
Core it Dual
Model / Ref / Catalog
#2101BL EUDAMED
101-0302 GUDID
Primary DI / UDI-DI
08809262954845
Basic UDI-DI
B-08809262954845
510(k) Number
FDA product code
EBF
EMDN code
Q01010103 Dental restorative composites
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
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
#2101BL
GUDID
101-0302
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: Dental composite resin

Cleared under the same submission (K092572)

and 1 more cleared under K092572

Similar devices in this category

Other devices filed under DENTAL RESTORATIVE COMPOSITES.

Other devices from Spident Co., Ltd.

See all devices from Spident Co., Ltd. →

Properties

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