Cleared Traditional

K884308 - MANDIBLE MANIPULATOR (FDA 510(k) Clearance)

Class I Dental device.

K884308 · Leonard Medical, Inc. · Dental device
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Mar 1989
Decision
169d
Days
Class 1
Risk

K884308 is an FDA 510(k) clearance for the MANDIBLE MANIPULATOR. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Leonard Medical, Inc. (Huntingdon Valley, US). The FDA issued a Cleared decision on March 31, 1989 after a review of 169 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Leonard Medical, Inc. devices

Submission Details

510(k) Number K884308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1988
Decision Date March 31, 1989
Days to Decision 169 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 127d · This submission: 169d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKJ Burnisher, Operative
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.