Cleared Traditional

K875340 - JETPOLISHER(TM)
(FDA 510(k) Clearance)

K875340 · Young Dental Manufacturing Co. 1, LLC · Dental
Jun 1988
Decision
163d
Days
Class 2
Risk

K875340 is an FDA 510(k) clearance for the JETPOLISHER(TM), 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 June 10, 1988, 163 days after receiving the submission on December 30, 1987. This device falls under the Dental review panel. Regulated under 21 CFR 872.6080.

Submission Details

510(k) Number K875340 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 1987
Decision Date June 10, 1988
Days to Decision 163 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