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GC Initial™ 010324

by Gc America Inc. 2 variants

GC Initial™ 010324 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 Oct 2022 (UDI-DI 14548161315425), 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) K153136

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 Number14548161315425 UDI-DI Date11 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153136 Date30 Jun 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153136 decided 30 Jun 2016 Active
  • FDA GUDID UDI-DI 14548161315425 listed 11 Oct 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153136
  2. Listed FDA GUDID 14548161315425

Coverage

1 jurisdiction

United States of America
  • 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  • Withdrawn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
010324
Primary DI / UDI-DI
14548161315425
510(k) Number
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

Related devices

Category: Dental appliance fabrication material, ceramic

Cleared under the same submission (K153136)

and 8 more cleared under K153136

Similar devices in this category

Other devices filed under Dental appliance fabrication material, ceramic.

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)