Cleared Traditional

K970589 - MICROETCHER AP

K970589 is an FDA 510(k) clearance for MICROETCHER AP, manufactured by Danville Engineering, Inc.. The device is a Class 2 Dental device with product code KOJ cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K970589 · Danville Engineering, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
211d
Days
Class 2
Risk

K970589 is an FDA 510(k) clearance for the MICROETCHER AP. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Danville Engineering, Inc. (San Ramon, US). The FDA issued a Cleared decision on September 17, 1997 after a review of 211 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 Danville Engineering, Inc. devices

FDA 510(k) Submission Details - K970589

510(k) Number K970589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1997
Decision Date September 17, 1997
Days to Decision 211 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 127d · This submission: 211d
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 16
Devices cleared under the same product code (KOJ) and FDA review panel - the closest regulatory comparables to K970589.
AIRPREP SYSTEM - MODEL 9001
K974488 · Asi Medical, Inc. · May 1998
ULTRA-BLASTER
K980726 · Ultradent Products, Inc. · May 1998
AEROETCHER
K973679 · Parkell, Inc. · Mar 1998
MICROJET CAVITY PREPARATION SYSTEM
K964755 · Midwest Dental Products Corp. · Sep 1997
ACCU-PREP
K970484 · Bisco, Inc. · Jul 1997
SIMPLEX AIRBRATOR
K970249 · Simplex Medical Systems, Inc. · May 1997