FDA 510(k)

Triumph Resin Dam

K-Number: K151945 · 2016-02-18

Decision Date2016-02-18

Product CodeEIE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Triumph Resin Dam is the device name listed in this FDA 510(k) record. The listed applicant is Denali Corporation. It received FDA 510(k) clearance on 2016-02-18 under 510(k) 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. The listed applicant is Denali Corporation. The 510(k) number is K151945.

When did Triumph Resin Dam receive FDA 510(k) clearance?

Triumph Resin Dam received FDA 510(k) clearance on 2016-02-18, under 510(k) number K151945.

Who is the listed applicant for Triumph Resin Dam?

The FDA 510(k) record lists Denali Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Triumph Resin Dam?

The FDA product code for Triumph Resin Dam is EIE.

Other records listing Denali Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.