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G-aenial™ 012281

by Gc America Inc. 2 variants

G-aenial™ 012281 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K173500 on 8 Mar 2018 and listed in FDA GUDID since 1 Oct 2018 (UDI-DI D0470122811), 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) K173500

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 NumberD0470122811 UDI-DI Date1 Oct 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173500 Date8 Mar 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173500 decided 8 Mar 2018 Active
  • FDA GUDID UDI-DI D0470122811 listed 1 Oct 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173500
  2. Listed FDA GUDID D0470122811

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
G-aenial™
Generic name
Dental composite resin
Model / Ref / Catalog
012281
Primary DI / UDI-DI
D0470122811
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 (K173500)

and 8 more cleared under K173500

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

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