Triumph Resin Dam
K-Number: K151945 · 2016-02-18
ApplicantDenali Corporation
Decision Date2016-02-18
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Triumph Resin Dam is a medical device manufactured by Denali Corporation. It received FDA 510(k) clearance on 2016-02-18 under approval number K151945. The device is classified under product code EIE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Triumph Resin Dam?
Triumph Resin Dam is a medical device that received FDA 510(k) clearance on 2016-02-18. It is manufactured by Denali Corporation. The 510(k) number is K151945.
When was Triumph Resin Dam approved by the FDA?
Triumph Resin Dam received FDA 510(k) clearance on 2016-02-18, under approval number K151945.
What company makes Triumph Resin Dam?
Triumph Resin Dam is manufactured by Denali Corporation.
What is the FDA product code for Triumph Resin Dam?
The FDA product code for Triumph Resin Dam is EIE.
Other Devices by Denali Corporation
Related Devices (Code: EIE)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.