Cleared Traditional

BETA-POWDER

K063236 · Brainbase Corporation · Dental
Feb 2007
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K063236 is an FDA 510(k) clearance for the BETA-POWDER, a Airbrush (Class II — Special Controls, product code KOJ), submitted by Brainbase Corporation (Shinagawa-Ku Tokyo, JP). The FDA issued a Cleared decision on February 16, 2007, 114 days after receiving the submission on October 25, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.6080.

Submission Details

510(k) Number K063236 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 2006
Decision Date February 16, 2007
Days to Decision 114 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