Cleared Traditional

K033675 - PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER

K033675 is an FDA 510(k) clearance for PROSMILE AIR POLISHER AND PROPHYLAXIS P..., manufactured by Sirona Dental Systems GmbH. The device is a Class 2 Dental device with product code KOJ cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K033675 · Sirona Dental Systems GmbH · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
52d
Days
Class 2
Risk

K033675 is an FDA 510(k) clearance for the PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Sirona Dental Systems GmbH (North Attleboro, US). The FDA issued a Cleared decision on January 15, 2004 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6080 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K033675

510(k) Number K033675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 128d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOJ Device Classification - Class 2, Special Controls

Product Code KOJ Airbrush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6080
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KOJ Airbrush

All 47
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K033675 · PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
Download PDF FDA Summary Sirona Dental Systems…