Skip to content

everStick® 900833

by Gc America Inc.

Ref 900833

everStick® 900833 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 8 Oct 2026 (Basic UDI-DI ++J022MD0118KA), cleared under FDA 510(k) K011788 on 5 Nov 2001 and listed in FDA GUDID since 29 Jul 2022 (UDI-DI 15400556008703), 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) K011788

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/MDR EUDAMED Number++J022MD0118KA Basic UDI-DI 15400556008703UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15400556008703 UDI-DI Date29 Jul 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK011788 Date5 Nov 2001DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++J022MD0118KA registered 8 Oct 2026 Active
  • FDA 510(k) K011788 decided 5 Nov 2001 Active
  • FDA GUDID UDI-DI 15400556008703 listed 29 Jul 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K011788
  2. Listed FDA GUDID 15400556008703
  3. Registered EUDAMED ++J022MD0118KA

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  • Withdrawn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
everStickC&B EUDAMED
everStick® GUDID
Generic name
Dental reinforcing fibre
Model / Ref / Catalog
900833
Primary DI / UDI-DI
15400556008703
Basic UDI-DI
++J022MD0118KA
Direct marketing DI
15400556017989
510(k) Number
FDA product code
EBI
EMDN code
Q010299 Prosthetic dentistry devices - other
GMDN term
Dental reinforcing fibre
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3760
EU registration type
Standard device
EU market of registration
Belgium
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.

Related devices

Category: Dental reinforcing fibre

Cleared under the same submission (K011788)

Similar devices in this category

Other devices filed under DEVICES FOR PROSTHETIC DENTISTRY.

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)