Cleared Traditional

DENTAL INSTRUMENTS - CUTTING INSTRUMENT

K823326 · Miltex, Inc. · Dental
Nov 1982
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K823326 is an FDA 510(k) clearance for the DENTAL INSTRUMENTS - CUTTING INSTRUMENT, a Instrument, Hand, Calculus Removal (Class I — General Controls, product code ELA), submitted by Miltex, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 24, 1982, 16 days after receiving the submission on November 8, 1982. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K823326 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 1982
Decision Date November 24, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code ELA — Instrument, Hand, Calculus Removal
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565