Clearance Summary
Triumph Resin Dam received FDA 510(k) clearance under submission number K151945, sponsored by Denali Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2016-02-18.
- Submission: K151945
- Applicant / Sponsor: Denali Corporation
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6300
- Decision date: 2016-02-18
Classification & Regulation
This clearance is catalogued under FDA product code EIE and 21 CFR 872.6300, within the Dental review panel as a Class I device.