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G-Cem Universal

by Gc America Inc.

510(k) K254109

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK254109 Date18 May 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
EMA
FDA applicant
GC America, Inc.
Device class
Class II
Regulation
21 CFR Part 872.3275
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The G-Cem Universal is a dental cement. It is used for cementation of various types of restorations, including metal-based, resin, and all-ceramic inlays, onlays, crowns, bridges, and posts.

The device is supplied as a self-adhesive resin cement and is indicated for use in dental procedures. It is a non-technique sensitive and versatile product, and its use is not limited to specific types of restorations or posts. The device has a product code of EMA and is regulated under regulation number 872.3275.

Other devices from Gc America Inc.

See all devices from Gc America Inc. →

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the G-Cem Universal used for?

    The G-Cem Universal is used for cementation of various types of restorations, including metal-based, resin, and all-ceramic inlays, onlays, crowns, bridges, and posts.

  • Is the G-Cem Universal a technique-sensitive product?

    No, the G-Cem Universal is a non-technique sensitive product, making it versatile and easy to use in various dental procedures.

  • What is the product code of the G-Cem Universal?

    The product code of the G-Cem Universal is EMA, and it is regulated under regulation number 872.3275.

  • How is the G-Cem Universal supplied?

    The G-Cem Universal is supplied as a self-adhesive resin cement.