Not currently registered with FDA under this name
Denali Corporation
Hanover, MA, United States. Named as applicant on 9 dental 510(k) clearances between 2007 and 2016. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 92007–2016
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2000–2026
510(k) clearances
Clearances on which FDA names Denali Corporation as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 26 Feb 2016 | K153191 | Calcium Bridge | EBF Resin Tooth Shade Material |
| 18 Feb 2016 | K151945 | Triumph Resin Dam | EIE Rubber Dam |
| 16 Dec 2015 | K152322 | Resolve 2.0 | PME External Cleaning Solution |
| 10 Nov 2014 | K141503 | DENALI 501CEMENT | EMA Dental Cement |
| 14 Mar 2014 | K132393 | CERCOM II CEMENT | EMA Dental Cement |
| 17 Jan 2008 | K073101 | AURAVENEER CEMENT | EMA Dental Cement |
| 5 Jun 2007 | K071158 | AURALAY PIT & FISSURE SEALANT | EBC Pit and Fissure Sealant and Conditioner |
| 10 May 2007 | K070702 | FUSION RESIN CEMENT AND CORE KIT | EBF Resin Tooth Shade Material |
| 9 May 2007 | K070693 | AURAVUE PIT & FISSURE SEALANT | EBF Resin Tooth Shade Material |
Some of these clearances are listed with FDA today by another company: Denali R & D Corporation (9), George Taub Products & Fusion Co., Inc. (7), Prismatik Dentalcraft, Inc. (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.