Triumph Resin Dam— 510(k) K151945

Substantially Equivalent

Denali Corporation

FDA 510(k) clearance K151945 for Triumph Resin Dam, Substantially Equivalent on 2016-02-18. Applicant: Denali Corporation. Device class: 1.

Clearance details

Applicant: Denali Corporation
Product code: Code EIE
Device class: Class 1
Regulation: 21 CFR 872.6300
Advisory panel: Dental
Date received: 2015-07-14
Decision date: 2016-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hanover, MA, US

Download summary PDF View on FDA.gov ↗

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