Triumph Resin Dam
FDA 510(k) K151945 · Denali Corporation
510(k) numberK151945
Submission
- Device name
- Triumph Resin Dam
- Applicant
- Denali Corporation
Hanover, MA, US - Received
- July 14, 2015
- Decision date
- February 18, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K182118 | armor LCEIE · Traditional | Mavrik Dental Systems, Ltd. | 05/03/2019SE |
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| K043301 | GC Tion Gingival ProtectorEIE · Traditional | GC America, Inc. | 01/25/2005SE |
| K040797 | Britesmile Masking CreamEIE · Special | Britesmile, Inc. | 04/02/2004SE |
| K022522 | Pulpdent Putty DamEIE · Traditional | Pulpdent Corporation | 09/26/2002SE |
| K021524 | Light Cure Dental DamEIE · Traditional | Prime Dental Manufacturing, Inc. | 07/19/2002SE |
| K021613 | Niveous Liquid DamEIE · Traditional | Shofu Dental Corp. | 06/20/2002SE |
| K010935 | Britesmile Barrier MaterialEIE · Traditional | Britesmile, Inc. | 09/05/2001SE |
| K983227 | Power BlockEIE · Traditional | Kreativ, Inc. | 12/11/1998SE |
| K972775 | FastdamEIE · Traditional | Interdent, Inc. | 02/27/1998SE |
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| 510(k) | Device | Decision |
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| K153191 | Calcium BridgeEBF · Traditional | 02/26/2016SE |
| K152322 | Resolve 2.0PME · Traditional | 12/16/2015SE |
| K141503 | Denali 501CEMENTEMA · Traditional | 11/10/2014SE |
| 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 Triumph Resin Dam cleared by the FDA?
Triumph Resin Dam (K151945) received a 510(k) decision of Substantially Equivalent on February 18, 2016, 219 days after the submission was received.
What is the product code of K151945?
The FDA product code is EIE – Dam, Rubber, a Class I (low risk) device regulated under 21 CFR 872.6300.