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G-aenial™ 012365

by Gc America Inc.

G-aenial™ 012365 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 15 Mar 2019 (UDI-DI D0470123651), 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 NumberD0470123651 UDI-DI Date15 Mar 2019ListedStatusListed 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 D0470123651 listed 15 Mar 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173500
  2. Listed FDA GUDID D0470123651

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  • Withdrawn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
012365
Primary DI / UDI-DI
D0470123651
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
Size
Total Volume — 1 Milliliter

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

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)