Cleared Traditional

ORTHODONTIC ELASTOMERIC SEPARATOR MODULE (K943418) - FDA 510(k) Clearance

Class I Dental device.

K943418 · Jon-Ko Products, Inc. · Dental device
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May 1995
Decision
312d
Days
Class 1
Risk

K943418 is an FDA 510(k) clearance for the ORTHODONTIC ELASTOMERIC SEPARATOR MODULE. Classified as Band, Elastic, Orthodontic (product code ECI), Class I - General Controls.

Submitted by Jon-Ko Products, Inc. (San Diego, US). The FDA issued a Cleared decision on May 23, 1995 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5410 - 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 Jon-Ko Products, Inc. devices

Submission Details

510(k) Number K943418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1994
Decision Date May 23, 1995
Days to Decision 312 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
185d slower than avg
Panel avg: 127d · This submission: 312d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ECI Band, Elastic, Orthodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5410
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.