Cleared Traditional

YOUNG PROPHY SYSTEM, PS UNIT

K903284 · Young Dental Manufacturing Co. 1, LLC · Dental
Dec 1990
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K903284 is an FDA 510(k) clearance for the YOUNG PROPHY SYSTEM, PS UNIT, a Airbrush (Class II — Special Controls, product code KOJ), submitted by Young Dental Manufacturing Co. 1, LLC (Earth City, US). The FDA issued a Cleared decision on December 17, 1990, 148 days after receiving the submission on July 22, 1990. This device falls under the Dental review panel. Regulated under 21 CFR 872.6080.

Submission Details

510(k) Number K903284 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1990
Decision Date December 17, 1990
Days to Decision 148 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code KOJ — Airbrush
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6080