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GC Fuji LINING™ 000128

by Gc America Inc.

Ref 000128

GC Fuji LINING™ 000128 is a device classified as Class IIa in the EU and Class II in the US made by Gc America Inc., registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI ++J022MD0089KU), cleared under FDA 510(k) K901999 on 31 Jul 1990 and listed in FDA GUDID since 19 Aug 2022 (UDI-DI 14548161294300), 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) K901999

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++J022MD0089KU Basic UDI-DI 14548161294300UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14548161294300 UDI-DI Date19 Aug 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK901999 Date31 Jul 1990DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++J022MD0089KU registered 19 Oct 2026 Active
  • FDA 510(k) K901999 decided 31 Jul 1990 Active
  • FDA GUDID UDI-DI 14548161294300 listed 19 Aug 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K901999
  2. Listed FDA GUDID 14548161294300
  3. Registered EUDAMED ++J022MD0089KU

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  • Withdrawn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
GC Fuji LINING™ LC EUDAMED
GC Fuji LINING™ GUDID
Generic name
Glass ionomer dental cement
Model / Ref / Catalog
000128
Primary DI / UDI-DI
14548161294300
Basic UDI-DI
++J022MD0089KU
Direct marketing DI
14548161353779
510(k) Number
FDA product code
EJK
EMDN code
Q01010106 Dental restoration glass ionomers
GMDN term
Glass ionomer dental cement
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3250
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 6.8 Milliliter

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: Glass ionomer dental cement

Cleared under the same submission (K901999)

and 1 more cleared under K901999

Similar devices in this category

Other devices filed under DENTAL RESTORATION GLASS IONOMERS.

Other devices from Gc America Inc.

See all devices from Gc America Inc. →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)