Cleared Traditional

K883120 - FLEX PLASTIC PLASTIC COATED NITINOL ARC...

K883120 is an FDA 510(k) clearance for FLEX PLASTIC PLASTIC COATED NITINOL ARC..., manufactured by Flexmedics. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 111-day FDA review.

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

FDA 510(k) Submission Details - K883120

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.

EJF Device Classification - Class 1, General Controls

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.