Cleared Traditional

K863836 - POST TRAY (FDA 510(k) Clearance)

Oct 1986
Decision
14d
Days
Class 1
Risk

K863836 is an FDA 510(k) clearance for the POST TRAY. This device is classified as a Tray, Impression, Preformed (Class I - General Controls, product code EHY).

Submitted by Market Masters, Inc. (Lansing, US). The FDA issued a Cleared decision on October 14, 1986, 14 days after receiving the submission on September 30, 1986.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6880.

Submission Details

510(k) Number K863836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1986
Decision Date October 14, 1986
Days to Decision 14 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code EHY — Tray, Impression, Preformed
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.6880