Cleared Traditional

K980216 - KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6

K980216 is an FDA 510(k) clearance for KREATIV MACH 5, manufactured by Kreativ, Inc.. The device is a Class 2 Dental device with product code KOJ cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K980216 · Kreativ, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
146d
Days
Class 2
Risk

K980216 is an FDA 510(k) clearance for the KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Kreativ, Inc. (Albany, US). The FDA issued a Cleared decision on June 16, 1998 after a review of 146 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.

View all Kreativ, Inc. devices

FDA 510(k) Submission Details - K980216

510(k) Number K980216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1998
Decision Date June 16, 1998
Days to Decision 146 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
19d slower than avg
Panel avg: 127d · This submission: 146d
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 18
Devices cleared under the same product code (KOJ) and FDA review panel - the closest regulatory comparables to K980216.
JETSONIC 2000
K990545 · Sds Dental, Inc. · Aug 1999
AIR TECHNIQUES' AIRDENT II
K981564 · Air Techniques, Inc. · Sep 1998
PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM
K974655 · Prep Technology Corp. · Jul 1998
AIRPREP SYSTEM - MODEL 9001
K974488 · Asi Medical, Inc. · May 1998
ULTRA-BLASTER
K980726 · Ultradent Products, Inc. · May 1998
AEROETCHER
K973679 · Parkell, Inc. · Mar 1998