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everStick® 900834

by Gc America Inc.

everStick® 900834 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K011788 on 5 Nov 2001 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI J0229008341), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K011788

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberJ0229008341 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK011788 Date5 Nov 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K011788 decided 5 Nov 2001 Active
  • FDA GUDID UDI-DI J0229008341 listed 1 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K011788
  2. Listed FDA GUDID J0229008341

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
everStick®
Generic name
Dental reinforcing fibre
Model / Ref / Catalog
900834
Primary DI / UDI-DI
J0229008341
510(k) Number
FDA product code
EBI
GMDN term
Dental reinforcing fibre
Device class
Class II
Regulation number
872.3760
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental reinforcing fibre

Cleared under the same submission (K011788)

Similar devices in this category

Other devices filed under Dental reinforcing fibre.

Other devices from Gc America Inc.

See all devices from Gc America Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)