iCEM Universal Plus
FDA 510(k) K254063 · Kulzer, LLC
510(k) numberK254063
Submission
- Device name
- iCEM Universal Plus
- Applicant
- Kulzer, LLC
South Bend, IN, US - Received
- December 17, 2025
- Decision date
- December 19, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
| 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 |
|---|---|---|
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneEBF · Traditional | 03/11/2026SE |
| K243910 | RetraxilMVL · Traditional | 09/24/2025SE |
| K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite…EBF · Traditional | 09/17/2024SE |
| K233868 | dima Print Teeth & TempEBG · Traditional | 05/23/2024SE |
| K230644 | Signum opaque FEBF · Traditional | 09/07/2023SE |
| K220605 | Venus Bulk Flow ONEEBF · Special | 04/21/2022SE |
| K905058 | Palavit LEBH · Traditional | 06/06/1991SE |
| K904928 | Palavit GLCEGD · Traditional | 06/06/1991SE |
| K910263 | CharismaEBF · Traditional | 06/03/1991SE |
| K910719 | Silicoater MDEMA · Traditional | 04/29/1991SE |
Questions and answers
When was iCEM Universal Plus cleared by the FDA?
iCEM Universal Plus (K254063) received a 510(k) decision of Substantially Equivalent on December 19, 2025, 2 days after the submission was received.
What is the product code of K254063?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.