Cleared Traditional

K862286 - ARTHROPHONOMETER (FDA 510(k) Clearance)

Class I Dental device.

K862286 · Arthrotek, Inc. · Dental device
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Jan 1987
Decision
205d
Days
Class 1
Risk

K862286 is an FDA 510(k) clearance for the ARTHROPHONOMETER. Classified as Device, Dental Sonography, For Monitoring Jaw Sounds (product code NFQ), Class I - General Controls.

Submitted by Arthrotek, Inc. (West Hartford, US). The FDA issued a Cleared decision on January 7, 1987 after a review of 205 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.2050 - 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 Arthrotek, Inc. devices

Submission Details

510(k) Number K862286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1986
Decision Date January 07, 1987
Days to Decision 205 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 127d · This submission: 205d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NFQ Device, Dental Sonography, For Monitoring Jaw Sounds
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.2050
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.