G-Cem Universal
FDA 510(k) K254109 · GC America, Inc.
510(k) numberK254109
Submission
- Device name
- G-Cem Universal
- Applicant
- GC America, Inc.
Alsip, IL, US - Received
- December 19, 2025
- Decision date
- May 18, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EMA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254201 | Any-CemEMA · Traditional | Mediclus Co., Ltd. | 08/13/2026SE |
| K261937 | PacTemp Automix NEEMA · Traditional | The Belport Company Inc., DBA Gingi-Pak | 08/07/2026SE |
| K261166 | Dia-CemEMA · Traditional | DiaDent Group International | 07/09/2026SE |
| K253337 | REGEN Bioactive CementEMA · Traditional | Inter-Med, Inc. | 04/15/2026SE |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-InEMA · Traditional | Voco GmbH | 03/20/2026SE |
| K254063 | iCEM Universal PlusEMA · Abbreviated | Kulzer, LLC | 12/19/2025SE |
| K252785 | TopCEM Vigor SA Self-Adhesive Resin CementEMA · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/12/2025SE |
| K252808 | GlasIonomer FX-LCEMA · Traditional | Shofu Dental Corporation | 12/09/2025SE |
| K252165 | Zirconomer PEMA · Traditional | Shofu Dental Corporation | 10/28/2025SE |
| K250953 | Equia LC OneEMA · Traditional | GC America, Inc. | 09/19/2025SE |
More from GC America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262202 | Cerasmart ForteEBF · Traditional | 09/10/2026SE |
| K253317 | Cytrans ElashieldLYC · Traditional | 07/06/2026SE |
| K261246 | SRGC-06EBF · Traditional | 06/18/2026SE |
| K251124 | G-Bond UniversalKLE · Traditional | 10/02/2025SE |
| K250953 | Equia LC OneEMA · Traditional | 09/19/2025SE |
| K251946 | G aenial Universal Injectable IIEBF · Traditional | 08/29/2025SE |
| K200798 | G-Cem OneEMA · Traditional | 11/24/2020SE |
| K200682 | BZF-29KLE · Traditional | 10/02/2020SE |
| K192597 | Cytrans GranulesLYC · Abbreviated | 08/17/2020SE |
| K193113 | GC Temp PrintEBG · Traditional | 07/09/2020SE |
Questions and answers
When was G-Cem Universal cleared by the FDA?
G-Cem Universal (K254109) received a 510(k) decision of Substantially Equivalent on May 18, 2026, 150 days after the submission was received.
What is the product code of K254109?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.