Cleared Traditional

K990060 - MACH 7

K990060 is an FDA 510(k) clearance for MACH 7, 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 524-day FDA review.

K990060 · Kreativ, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
524d
Days
Class 2
Risk

K990060 is an FDA 510(k) clearance for the MACH 7. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Kreativ, Inc. (San Diego, US). The FDA issued a Cleared decision on June 15, 2000 after a review of 524 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.

FDA 510(k) Submission Details - K990060

510(k) Number K990060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1999
Decision Date June 15, 2000
Days to Decision 524 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
396d slower than avg
Panel avg: 128d · This submission: 524d
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 46
Devices cleared under the same product code (KOJ) and FDA review panel - the closest regulatory comparables to K990060.
DISPOPROPHY
K993182 · Kis Products · Aug 2001
DENTO-PREP PARTICLE MICROBLASTER
K010816 · Ronvig A/S · May 2001
KAVO CORUND HANDPIECE 2013
K002708 · Kavo America · Nov 2000
AIRDENT II CS
K001313 · Air Technologies, Inc. · Jun 2000
SIMPLEX AIRBRATOR (SAB-7)
K980672 · Irt Management Corp. · May 2000
S.S. WHITE TECHNOLOGIES, MODELS 6500-D,6500-E, AND 6500-F
K984415 · S.S. White Technologies, Inc. · Sep 1999
K990060 · MACH 7
Download PDF FDA Summary Kreativ, Inc.