TopCEM Vigor SA Self-Adhesive Resin Cement
FDA 510(k) K252785 · Rizhao Huge Biomaterials Company, Ltd.
510(k) numberK252785
Submission
- Device name
- TopCEM Vigor SA Self-Adhesive Resin Cement
- Applicant
- Rizhao Huge Biomaterials Company, Ltd.
Rizhao, CN - Received
- September 2, 2025
- Decision date
- December 12, 2025
- 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 |
| K254109 | G-Cem UniversalEMA · Traditional | GC America, Inc. | 05/18/2026SE |
| 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 |
| 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 |
|---|---|---|
| K251271 | TempFIT Temporary Crown and Bridge ResinEBG · Traditional | 06/23/2025SE |
| K242572 | TopCEM-Try in Veneer Try-in GelEBF · Traditional | 12/20/2024SE |
| K242530 | HF-Etchant Hydrofluoric Acid Etching GelKLE · Traditional | 12/20/2024SE |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling AgentKLE · Traditional | 11/08/2024SE |
| K241204 | TopCEM-Veneer Light Cure Veneer CementEMA · Traditional | 06/28/2024SE |
| K233082 | TopCEM Dual Cure Resin CementEBF · Traditional | 12/22/2023SE |
| K230455 | Enamel Coating ResinEBC · Traditional | 07/25/2023SE |
| K221510 | TrusFIL-Flow Flowable Composite RestorativeEBF · Traditional | 10/12/2022SE |
| K221450 | Phosphoric Acid Etching GelKLE · Traditional | 09/12/2022SE |
| K202063 | TrusFIL Universal Composite RestorativeEBF · Traditional | 10/06/2021SE |
Questions and answers
When was TopCEM Vigor SA Self-Adhesive Resin Cement cleared by the FDA?
TopCEM Vigor SA Self-Adhesive Resin Cement (K252785) received a 510(k) decision of Substantially Equivalent on December 12, 2025, 101 days after the submission was received.
What is the product code of K252785?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.