Denali 501CEMENT
FDA 510(k) K141503 · Denali Corporation
510(k) numberK141503
Submission
- Device name
- Denali 501CEMENT
- Applicant
- Denali Corporation
Hanover, MA, US - Received
- June 6, 2014
- Decision date
- November 10, 2014
- 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 |
|---|---|---|
| K153191 | Calcium BridgeEBF · Traditional | 02/26/2016SE |
| K151945 | Triumph Resin DamEIE · Traditional | 02/18/2016SE |
| K152322 | Resolve 2.0PME · Traditional | 12/16/2015SE |
| K132393 | Cercom II CementEMA · Traditional | 03/14/2014SE |
| K073101 | Auraveneer CementEMA · Traditional | 01/17/2008SE |
| K071158 | Auralay Pit & Fissure SealantEBC · Traditional | 06/05/2007SE |
| K070702 | Fusion Resin Cement and Core KitEBF · Traditional | 05/10/2007SE |
| K070693 | Auravue Pit & Fissure SealantEBF · Traditional | 05/09/2007SE |
Questions and answers
When was Denali 501CEMENT cleared by the FDA?
Denali 501CEMENT (K141503) received a 510(k) decision of Substantially Equivalent on November 10, 2014, 157 days after the submission was received.
What is the product code of K141503?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.