Cleared Traditional

K021450 - CLINPRO PROPHY POWDER

K021450 is an FDA 510(k) clearance for CLINPRO PROPHY POWDER, manufactured by 3M Espe AG Dental Products. The device is a Class 2 Dental device with product code KOJ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K021450 · 3M Espe AG Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
87d
Days
Class 2
Risk

K021450 is an FDA 510(k) clearance for the CLINPRO PROPHY POWDER. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by 3M Espe AG Dental Products (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on August 1, 2002 after a review of 87 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.

View all 3M Espe AG Dental Products devices

FDA 510(k) Submission Details - K021450

510(k) Number K021450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2002
Decision Date August 01, 2002
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
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 7
Devices cleared under the same product code (KOJ) and FDA review panel - the closest regulatory comparables to K021450.
turbodent touch
K251425 · Mectron S.P.A. · May 2025
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
K033675 · Sirona Dental Systems GmbH · Jan 2004
NEW PROPHY POWDER
K014188 · Dentsply Intl. · Mar 2002
ULTRA-BLASTER
K980726 · Ultradent Products, Inc. · May 1998
AEROETCHER
K973679 · Parkell, Inc. · Mar 1998
ACCU-PREP
K970484 · Bisco, Inc. · Jul 1997