Cleared Traditional

SEPTOCAL CAVITY LINER

K913574 · Specialites Septodont · Dental
Sep 1991
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K913574 is an FDA 510(k) clearance for the SEPTOCAL CAVITY LINER, a Liner, Cavity, Calcium Hydroxide (Class II — Special Controls, product code EJK), submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on September 30, 1991, 49 days after receiving the submission on August 12, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.3250.

Submission Details

510(k) Number K913574 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1991
Decision Date September 30, 1991
Days to Decision 49 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJK — Liner, Cavity, Calcium Hydroxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3250

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