Cleared Traditional

K973679 - AEROETCHER

K973679 is the FDA 510(k) clearance for AEROETCHER by Parkell, Inc.. It is a Class 2 Dental device (product code KOJ) cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K973679 · Parkell, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
165d
Days
Class 2
Risk

K973679 is an FDA 510(k) clearance for the AEROETCHER. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on March 10, 1998 after a review of 165 days - an extended review 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: 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 Parkell, Inc. devices

Submission Details

510(k) Number K973679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1997
Decision Date March 10, 1998
Days to Decision 165 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
38d slower than avg
Panel avg: 127d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.