GC Initial™ 012839

by Gc America Inc. 2 variants

GC Initial™ 012839 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K153136 on 30 Jun 2016 and listed in FDA GUDID since 11 Feb 2019 (UDI-DI D0470128391), 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	NumberD0470128391 UDI-DI	Date11 Feb 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK153136	Date30 Jun 2016Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K153136

Across registries

2 registries list this device

FDA 510(k) K153136 decided 30 Jun 2016 Active
FDA GUDID UDI-DI D0470128391 listed 11 Feb 2019 Listed

Timeline

2 dated events

30 Jun 2016 Cleared FDA 510(k) K153136
11 Feb 2019 Listed FDA GUDID D0470128391

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: GC Initial™
Generic name: Dental appliance fabrication material, ceramic
Model / Ref / Catalog: 012839

Primary DI / UDI-DI: D0470128391
510(k) Number: K153136
FDA product code: EIH
GMDN term: Dental appliance fabrication material, ceramic

Device class: Class II
Regulation number: 872.6660
GUDID distribution status: In Commercial Distribution

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Other devices filed under Dental appliance fabrication material, ceramic.

Other devices from Gc America Inc.

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Properties

Prescription use
Lot / batch number
Expiration date

Other properties (12, all answered No)