Cleared Traditional

RACESTYPTINE

K884653 · Specialites Septodont · Dental
Jan 1989
Decision
73d
Days
Class 1
Risk

About This 510(k) Submission

K884653 is an FDA 510(k) clearance for the RACESTYPTINE, a Burnisher, Operative (Class I — General Controls, product code EKJ), submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on January 19, 1989, 73 days after receiving the submission on November 7, 1988. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K884653 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 1988
Decision Date January 19, 1989
Days to Decision 73 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EKJ — Burnisher, Operative
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565