Cleared Traditional

AUTOPACK NON-EUGENOL PERIODONTAL DRESSING

K913572 · Specialites Septodont · Dental
Oct 1991
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K913572 is an FDA 510(k) clearance for the AUTOPACK NON-EUGENOL PERIODONTAL DRESSING, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on October 9, 1991, 58 days after receiving the submission on August 12, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K913572 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1991
Decision Date October 09, 1991
Days to Decision 58 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