Cleared Traditional

MAUNAL DISPOSABLE DENTAL INSTRUMENTS

K943351 · Magnum Instruments, Inc. · Dental
Oct 1994
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K943351 is an FDA 510(k) clearance for the MAUNAL DISPOSABLE DENTAL INSTRUMENTS, a Burnisher, Operative (Class I — General Controls, product code EKJ), submitted by Magnum Instruments, Inc. (Glendale Hts., US). The FDA issued a Cleared decision on October 7, 1994, 87 days after receiving the submission on July 12, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K943351 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 1994
Decision Date October 07, 1994
Days to Decision 87 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