Cleared Traditional

PREPAIR

K033215 · Danville Materials, Inc. · Dental
Jan 2004
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K033215 is an FDA 510(k) clearance for the PREPAIR, a Airbrush (Class II — Special Controls, product code KOJ), submitted by Danville Materials, Inc. (San Ramon, US). The FDA issued a Cleared decision on January 9, 2004, 98 days after receiving the submission on October 3, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.6080.

Submission Details

510(k) Number K033215 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2003
Decision Date January 09, 2004
Days to Decision 98 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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