Cleared Traditional

K984380 - DISPO ETCH

K984380 is an FDA 510(k) clearance for DISPO ETCH, manufactured by Kis Products. The device is a Class 2 Dental device with product code KOJ cleared through the Traditional 510(k) pathway after a 972-day FDA review.

K984380 · Kis Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
972d
Days
Class 2
Risk

K984380 is an FDA 510(k) clearance for the DISPO ETCH. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Kis Products (Fort Lauderdale, US). The FDA issued a Cleared decision on August 6, 2001 after a review of 972 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Kis Products devices

FDA 510(k) Submission Details - K984380

510(k) Number K984380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1998
Decision Date August 06, 2001
Days to Decision 972 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
845d slower than avg
Panel avg: 127d · This submission: 972d
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 27
Devices cleared under the same product code (KOJ) and FDA review panel - the closest regulatory comparables to K984380.
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
DISPODRILL
K993124 · Kis Products · Aug 2001
DISPOPROPHY
K993182 · Kis Products · Aug 2001
KAVO CORUND HANDPIECE 2013
K002708 · Kavo America · Nov 2000