Cleared Traditional

K934265 - FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE (FDA 510(k) Clearance)

Class I Dental device.

K934265 · Flexmedics · Dental device
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Jan 1994
Decision
143d
Days
Class 1
Risk

K934265 is an FDA 510(k) clearance for the FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE. Classified as Wire, Orthodontic (product code DZC), Class I - General Controls.

Submitted by Flexmedics (Minnetonka, US). The FDA issued a Cleared decision on January 21, 1994 after a review of 143 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 K934265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1993
Decision Date January 21, 1994
Days to Decision 143 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
16d slower than avg
Panel avg: 127d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DZC Wire, 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.