Insure® Universal; Insure® Universal Automix
FDA 510(k) K240714 · Cosmedent, Inc.
510(k) numberK240714
Submission
- Device name
- Insure® Universal; Insure® Universal Automix
- Applicant
- Cosmedent, Inc.
Chicago, IL, US - Received
- March 15, 2024
- Decision date
- July 24, 2024
- 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 |
| K252165 | Zirconomer PEMA · Traditional | Shofu Dental Corporation | 10/28/2025SE |
More from Shofu Dental Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K222435 | Renamel® Microhybrid ;Renamel® Flowable MicrohybridEBF · Traditional | 10/11/2022SE |
| K211259 | Renamel BulkfillEBF · Traditional | 06/24/2021SE |
| K172707 | Renamel MicrofillEBF · Traditional | 12/05/2017SE |
| K163480 | Renamel NANO +plusEBF · Traditional | 02/24/2017SE |
| K092730 | Cosmedent Brushable CompositeEBF · Traditional | 11/20/2009SE |
| K070583 | Nano CompositeEBF · Traditional | 04/16/2007SE |
| K060881 | Temporary Crown & Bridge ResinEBG · Traditional | 05/16/2006SE |
| K052263 | Multiple (Tooth Desensitizer)LBH · Traditional | 12/16/2005SE |
| K052501 | Multiple Resin Tooth Bonding AgentKLE · Traditional | 10/21/2005SE |
| K042823 | Cosmedent Pit & Fissure SealantEBC · Traditional | 12/01/2004SE |
Questions and answers
When was Insure® Universal; Insure® Universal Automix cleared by the FDA?
Insure® Universal; Insure® Universal Automix (K240714) received a 510(k) decision of Substantially Equivalent on July 24, 2024, 131 days after the submission was received.
What is the product code of K240714?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.