Cleared Traditional

Triumph Resin Dam

K151945 · Denali Corporation · Dental
Feb 2016
Decision
219d
Days
Class 1
Risk

About This 510(k) Submission

K151945 is an FDA 510(k) clearance for the Triumph Resin Dam, a Dam, Rubber (Class I — General Controls, product code EIE), submitted by Denali Corporation (Hanover, US). The FDA issued a Cleared decision on February 18, 2016, 219 days after receiving the submission on July 14, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.6300.

Submission Details

510(k) Number K151945 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2015
Decision Date February 18, 2016
Days to Decision 219 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIE — Dam, Rubber
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6300