Zirconomer P
FDA 510(k) K252165 · Shofu Dental Corporation
510(k) numberK252165
Submission
- Device name
- Zirconomer P
- Applicant
- Shofu Dental Corporation
San Marcos, CA, US - Received
- July 10, 2025
- Decision date
- October 28, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| K250953 | Equia LC OneEMA · Traditional | GC America, Inc. | 09/19/2025SE |
More from GC America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252808 | GlasIonomer FX-LCEMA · Traditional | 12/09/2025SE |
| K251470 | ResiCem EXEMA · Traditional | 07/11/2025SE |
| K251578 | Beautifil IIEBF · Traditional | 05/27/2025SE |
| K233161 | BeautiLink SAEMA · Traditional | 09/28/2023SE |
| K222253 | GlasIonomer FX ULTRAEMA · Traditional | 09/22/2022SE |
| K213965 | BeautiBond XtremeKLE · Traditional | 03/18/2022SE |
| K212939 | Vintage Prime PressEIH · Traditional | 03/18/2022SE |
| K200470 | Shofu Block HC HardEBF · Traditional | 02/05/2021SE |
| K191794 | Vintage Art UniversalEIH · Traditional | 10/03/2019SE |
| K182869 | Fit SAEBF · Traditional | 01/09/2019SE |
Questions and answers
When was Zirconomer P cleared by the FDA?
Zirconomer P (K252165) received a 510(k) decision of Substantially Equivalent on October 28, 2025, 110 days after the submission was received.
What is the product code of K252165?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.