# Denali Corporation

- Location (FDA's records): Hanover, MA
- FDA decisions: 9 (2007–2016): 9 510(k) clearances
- Product codes: EMA (3), EBF (3), EBC (1), EIE (1), PME (1)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ultradent Products, Inc.: 2 (https://510kreport.com/company/ultradent-products)
- Ivoclar North America, Inc.: 1 (https://510kreport.com/company/ivoclar-north-america)
- Sybron Dental Specialties, Inc.: 1 (https://510kreport.com/company/sybron-dental-specialties)
- Ivoclar Vivadent, Inc.: 1 (https://510kreport.com/company/ivoclar-vivadent)

## Firms that cite its devices most
- Mavrik Dental Systems, Ltd.: 1 (https://510kreport.com/company/mavrik-dental-systems)
- Bisco, Inc.: 1 (https://510kreport.com/company/bisco)

## Its most-cited devices
- K132393: Cercom II Cement (2014), cited by 1
- K151945: Triumph Resin Dam (2016), cited by 1
- K152322: Resolve 2.0 (2015), cited by 1

## Recent decisions
- K153191: Calcium Bridge (Feb 26, 2016)
- K151945: Triumph Resin Dam (Feb 18, 2016)
- K152322: Resolve 2.0 (Dec 16, 2015)
- K141503: Denali 501CEMENT (Nov 10, 2014)
- K132393: Cercom II Cement (Mar 14, 2014)
- K073101: Auraveneer Cement (Jan 17, 2008)
- K071158: Auralay Pit & Fissure Sealant (Jun 5, 2007)
- K070702: Fusion Resin Cement and Core Kit (May 10, 2007)

Source page: https://510kreport.com/company/denali
