RODIN Cement
FDA 510(k) K251775 · Belport Company, Inc., Gingi-Pak
510(k) numberK251775
Submission
- Device name
- RODIN Cement
- Applicant
- Belport Company, Inc., Gingi-Pak
Camarillo, CA, US - Received
- June 10, 2025
- Decision date
- September 2, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EMA
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|---|---|---|---|
| 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 |
| 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 |
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| 510(k) | Device | Decision |
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| K260430 | Porcelain Etch GelKLE · Traditional | 04/10/2026SE |
| K250279 | RC-SwiftPrepKJJ · Traditional | 07/02/2025SE |
| K250222 | SDF ProPHR · Traditional | 05/07/2025SE |
| K240688 | RODIN Titan 3D ResinEBI · Traditional | 06/20/2024SE |
| K231060 | ProMin Dental Desensitizing GelLBH · Traditional | 06/13/2024SE |
| K231793 | RODIN 3D Resin SPLINT, Hard/FlexMQC · Traditional | 03/26/2024SE |
| K223365 | RODIN Palette Naturalizing KitEBD · Traditional | 03/27/2023SE |
| K211420 | Stasis GelMVL · Traditional | 03/14/2022SE |
| K211419 | Gingi-Aid GelMVL · Traditional | 01/10/2022SE |
| K200462 | EtchPro Etching GelKLE · Traditional | 09/02/2020SE |
Questions and answers
When was RODIN Cement cleared by the FDA?
RODIN Cement (K251775) received a 510(k) decision of Substantially Equivalent on September 2, 2025, 84 days after the submission was received.
What is the product code of K251775?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.