Cleared Traditional

PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER

K033675 · Sirona Dental Systems GmbH · Dental
Jan 2004
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K033675 is an FDA 510(k) clearance for the PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER, a Airbrush (Class II — Special Controls, product code KOJ), submitted by Sirona Dental Systems GmbH (N. Attleboro, US). The FDA issued a Cleared decision on January 15, 2004, 52 days after receiving the submission on November 24, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.6080.

Submission Details

510(k) Number K033675 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2003
Decision Date January 15, 2004
Days to Decision 52 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