Cleared Traditional

K823321 - DENTAL INSTRUMENTS - CARVER
(FDA 510(k) Clearance)

K823321 · Miltex, Inc. · Dental
Nov 1982
Decision
16d
Days
Class 1
Risk

K823321 is an FDA 510(k) clearance for the DENTAL INSTRUMENTS - CARVER. This device is classified as a Carver, Dental Amalgam, Operative (Class I — General Controls, product code EKH).

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 K823321 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 EKH — Carver, Dental Amalgam, Operative
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565