Cleared Traditional

K771249 - JOY LIGHT
(FDA 510(k) Clearance)

Jul 1977
Decision
8d
Days
Class 1
Risk

K771249 is an FDA 510(k) clearance for the JOY LIGHT. This device is classified as a Light, Operating, Dental (Class I - General Controls, product code EAZ).

Submitted by M.D. Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 15, 1977, 8 days after receiving the submission on July 7, 1977.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4630.

Submission Details

510(k) Number K771249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1977
Decision Date July 15, 1977
Days to Decision 8 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code EAZ — Light, Operating, Dental
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.4630