Cleared Traditional

SILCOT COPAL CAVITY VARNISH

K895798 · Specialites Septodont · Dental
Dec 1989
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K895798 is an FDA 510(k) clearance for the SILCOT COPAL CAVITY VARNISH, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on December 21, 1989, 84 days after receiving the submission on September 28, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K895798 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 1989
Decision Date December 21, 1989
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

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