Cleared Traditional

SECURALLOY

K982671 · Specialites Septodont · Dental
Oct 1998
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K982671 is an FDA 510(k) clearance for the SECURALLOY, a Alloy, Amalgam (Class II — Special Controls, product code EJJ), submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on October 19, 1998, 80 days after receiving the submission on July 31, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.3070.

Submission Details

510(k) Number K982671 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 1998
Decision Date October 19, 1998
Days to Decision 80 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJJ — Alloy, Amalgam
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3070