Ultracem
FDA 510(k) K132255 · Ultradent Products Inc. / Oratech, LLC
510(k) numberK132255
Submission
- Device name
- Ultracem
- Applicant
- Ultradent Products Inc. / Oratech, LLC
South Jordan, UT, US - Received
- July 19, 2013
- Decision date
- October 24, 2013
- 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 |
| 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 |
More from Shofu Dental Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K132109 | EnamelastLBH · Traditional | 11/01/2013SE |
Questions and answers
When was Ultracem cleared by the FDA?
Ultracem (K132255) received a 510(k) decision of Substantially Equivalent on October 24, 2013, 97 days after the submission was received.
What is the product code of K132255?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.