Cleared Traditional

K940776 - KREATIV MODEL KV-1

K940776 is an FDA 510(k) clearance for KREATIV MODEL KV-1, 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 302-day FDA review.

K940776 · Kreativ, Inc. · Dental device
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Dec 1994
Decision
302d
Days
Class 2
Risk

K940776 is an FDA 510(k) clearance for the KREATIV MODEL KV-1. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Kreativ, Inc. (Vancouver, US). The FDA issued a Cleared decision on December 21, 1994 after a review of 302 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K940776

510(k) Number K940776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1994
Decision Date December 21, 1994
Days to Decision 302 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 127d · This submission: 302d
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 19
Devices cleared under the same product code (KOJ) and FDA review panel - the closest regulatory comparables to K940776.
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
MICROPREP CAVITY PREPERATION SYSTEM
K932997 · Sunrise Technologies, Inc. · Apr 1994
FIBER HEMOFILTERS FH55-FH77 & 88
K840720 · Gambro, Inc. · Apr 1984