Cleared Traditional

K823320 - DENTAL INSTRUMENTS - BONE CHISELS
(FDA 510(k) Clearance)

K823320 · Miltex, Inc. · Dental
Nov 1982
Decision
16d
Days
Class 1
Risk

K823320 is an FDA 510(k) clearance for the DENTAL INSTRUMENTS - BONE CHISELS. This device is classified as a Chisel, Bone, Surgical (Class I — General Controls, product code EML).

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 FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K823320 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 EML — Chisel, Bone, Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565