Cleared Traditional

K033215 - PREPAIR

K033215 is an FDA 510(k) clearance for PREPAIR, manufactured by Danville Materials, Inc.. The device is a Class 2 Dental device with product code KOJ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K033215 · Danville Materials, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
98d
Days
Class 2
Risk

K033215 is an FDA 510(k) clearance for the PREPAIR. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Danville Materials, Inc. (San Ramon, US). The FDA issued a Cleared decision on January 9, 2004 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Danville Materials, Inc. devices

FDA 510(k) Submission Details - K033215

510(k) Number K033215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 127d · This submission: 98d
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 12
Devices cleared under the same product code (KOJ) and FDA review panel - the closest regulatory comparables to K033215.
turbodent touch
K251425 · Mectron S.P.A. · May 2025
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
K033675 · Sirona Dental Systems GmbH · Jan 2004
CLINPRO PROPHY POWDER
K021450 · 3M Espe AG Dental Products · Aug 2002
NEW PROPHY POWDER
K014188 · Dentsply Intl. · Mar 2002
KAVO CORUND HANDPIECE 2013
K002708 · Kavo America · Nov 2000
JETSONIC 2000
K990545 · Sds Dental, Inc. · Aug 1999