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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 128d · 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 42
Devices cleared under the same product code (KOJ) and FDA review panel - the closest regulatory comparables to K033215.
BETA-POWDER
K063236 · Brainbase Corporation · Feb 2007
RONDOFLEX PLUS 360
K042872 · Kavo America Corporation · Nov 2004
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
K033675 · Sirona Dental Systems GmbH · Jan 2004
VELOPEX AQUACUT FLUID ABRASION UNIT
K024105 · Velopex International, Inc. · Oct 2003
GROMAN PREPMASTER
K030292 · Groman, Inc. · Apr 2003
CLINPRO PROPHY POWDER
K021450 · 3M Espe AG Dental Products · Aug 2002
K033215 · PREPAIR
Download PDF FDA Summary Danville Materials, I…