Cleared Traditional

K883120 - FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE (FDA 510(k) Clearance)

Class I Dental device.

K883120 · Flexmedics · Dental device
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Nov 1988
Decision
111d
Days
Class 1
Risk

K883120 is an FDA 510(k) clearance for the FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Flexmedics (Minneapolis, US). The FDA issued a Cleared decision on November 14, 1988 after a review of 111 days - within the typical 510(k) review window.

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. 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 Flexmedics devices

Submission Details

510(k) Number K883120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1988
Decision Date November 14, 1988
Days to Decision 111 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 127d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EJF Bracket, Metal, 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.