Cleared Traditional

K874335 - EXPLORER-DENTAL PROBER
(FDA 510(k) Clearance)

K874335 · Military Engineering, Inc. · Dental
Dec 1987
Decision
68d
Days
Class 1
Risk

K874335 is an FDA 510(k) clearance for the EXPLORER-DENTAL PROBER. This device is classified as a Burnisher, Operative (Class I — General Controls, product code EKJ).

Submitted by Military Engineering, Inc. (Plymouth, US). The FDA issued a Cleared decision on December 29, 1987, 68 days after receiving the submission on October 22, 1987.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K874335 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 1987
Decision Date December 29, 1987
Days to Decision 68 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

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