Cleared Traditional

ASEPTYLUM, UNI-CARRIER

K961714 · Distriflor S.A. · Dental
Jun 1996
Decision
39d
Days
Class 1
Risk

About This 510(k) Submission

K961714 is an FDA 510(k) clearance for the ASEPTYLUM, UNI-CARRIER, a Burnisher, Operative (Class I — General Controls, product code EKJ), submitted by Distriflor S.A. (Sandy, US). The FDA issued a Cleared decision on June 10, 1996, 39 days after receiving the submission on May 2, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K961714 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 1996
Decision Date June 10, 1996
Days to Decision 39 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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