Cleared Traditional

K964059 - MICADENT

K964059 is an FDA 510(k) clearance for MICADENT, manufactured by Hampton Research. The device is a Class 2 Dental device with product code KOJ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K964059 · Hampton Research · Dental device
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Dec 1996
Decision
71d
Days
Class 2
Risk

K964059 is an FDA 510(k) clearance for the MICADENT. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Hampton Research (Oklahoma City, US). The FDA issued a Cleared decision on December 19, 1996 after a review of 71 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hampton Research devices

FDA 510(k) Submission Details - K964059

510(k) Number K964059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1996
Decision Date December 19, 1996
Days to Decision 71 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
56d faster than avg
Panel avg: 127d · This submission: 71d
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 28
Devices cleared under the same product code (KOJ) and FDA review panel - the closest regulatory comparables to K964059.
ACCU-PREP
K970484 · Bisco, Inc. · Jul 1997
SIMPLEX AIRBRATOR
K970249 · Simplex Medical Systems, Inc. · May 1997
ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1
K964145 · Crystal Mark, Inc. · Dec 1996
OPTIBLAST INTRAORAL SANDBLASTER
K955573 · Buffalo Dental Mfg. Co., Inc. · May 1996
JETSTREAM CAVITY PREPARATION SYSTEM
K955050 · Dove Systems, Inc. · Mar 1996
MICROPREP CAVITY PREPERATION SYSTEM
K932997 · Sunrise Technologies, Inc. · Apr 1994