Cleared Traditional

SEPTOSIL SILICONE FOR PRECISION IMPRESSION

K851388 · Specialites Septodont · Dental
May 1985
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K851388 is an FDA 510(k) clearance for the SEPTOSIL SILICONE FOR PRECISION IMPRESSION, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on May 29, 1985, 50 days after receiving the submission on April 9, 1985. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K851388 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 1985
Decision Date May 29, 1985
Days to Decision 50 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code ELW — Material, Impression
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3660

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