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Gradia® 001980

by Gc America Inc. 2 variants

Gradia 001980 is a light-cured dental restorative composite resin (FDA Class II; FDA product code EBF, Material, Tooth Shade, Resin) made by Gc America Inc., cleared under FDA 510(k) K023814 on 30 Jan 2003 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI D0470019801), active as of 22 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 22 Oct 2026

Documents

510(k) K023814

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD0470019801 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK023814 Date30 Jan 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K023814 decided 30 Jan 2003 Active
  • FDA GUDID UDI-DI D0470019801 listed 1 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K023814
  2. Listed FDA GUDID D0470019801

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  • Withdrawn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
Light-cured dental restorative composite resin
Model / Ref / Catalog
001980
Description
GRADIA® DIRECT Unitips: 10 tips 0.16 mL AO2
Primary DI / UDI-DI
D0470019801
510(k) Number
FDA product code
EBF
GMDN term
Light-cured dental restorative composite resin
Device class
Class II
Regulation number
872.3690
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 0.16 Milliliter

Related devices

Category: Light-cured dental restorative composite resin

Cleared under the same submission (K023814)

and 8 more cleared under K023814

Similar devices

Other devices filed under FDA product code EBF (MATERIAL, TOOTH SHADE, RESIN).

Other devices from Gc America Inc.

See all devices from Gc America Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)