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Gradia® 901078

by Gc America Inc.

Gradia® 901078 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K153325 on 12 Jul 2016 and listed in FDA GUDID since 1 Sep 2021 (UDI-DI D0479010781), 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) K153325

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 NumberD0479010781 UDI-DI Date1 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153325 Date12 Jul 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153325 decided 12 Jul 2016 Active
  • FDA GUDID UDI-DI D0479010781 listed 1 Sep 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153325
  2. Listed FDA GUDID D0479010781

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  • Withdrawn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
901078
Primary DI / UDI-DI
D0479010781
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 (K153325)

and 8 more cleared under K153325

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)