GC Fuji® 009293

by Gc America Inc.

GC Fuji® 009293 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K172382 on 2 Apr 2018 and listed in FDA GUDID since 1 Feb 2019 (UDI-DI D0470092931), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberD0470092931 UDI-DI	Date1 Feb 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK172382	Date2 Apr 2018Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K172382

Across registries

2 registries list this device

FDA 510(k) K172382 decided 2 Apr 2018 Active
FDA GUDID UDI-DI D0470092931 listed 1 Feb 2019 Listed

Timeline

2 dated events

2 Apr 2018 Cleared FDA 510(k) K172382
1 Feb 2019 Listed FDA GUDID D0470092931

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: GC Fuji®
Generic name: Glass ionomer dental cement
Model / Ref / Catalog: 009293

Primary DI / UDI-DI: D0470092931
510(k) Number: K172382
FDA product code: EMA
GMDN term: Glass ionomer dental cement

Device class: Class II
Regulation number: 872.3275
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Lot / batch number
Expiration date

Other properties (12, all answered No)