Cleared Traditional

QUICKSET LIQUID AND POWDER

K982773 · Specialites Septodont · Dental
Nov 1998
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K982773 is an FDA 510(k) clearance for the QUICKSET LIQUID AND POWDER, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on November 3, 1998, 88 days after receiving the submission on August 7, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K982773 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 1998
Decision Date November 03, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275