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Gradia® 001419

by Gc America Inc. 2 variants

Gradia® 001419 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K001518 on 5 Jul 2000 and listed in FDA GUDID since 19 Aug 2022 (UDI-DI 14548161392075), 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) K001518

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 Number14548161392075 UDI-DI Date19 Aug 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK001518 Date5 Jul 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K001518 decided 5 Jul 2000 Active
  • FDA GUDID UDI-DI 14548161392075 listed 19 Aug 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K001518
  2. Listed FDA GUDID 14548161392075

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Gradia®
Generic name
Dental composite resin
Model / Ref / Catalog
001419
Primary DI / UDI-DI
14548161392075
510(k) Number
FDA product code
EBF
GMDN term
Dental composite resin
Device class
Class II
Regulation number
872.3690
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental composite resin

Cleared under the same submission (K001518)

and 8 more cleared under K001518

Similar devices in this category

Other devices filed under Dental composite resin.

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)