Cleared Traditional

K934265 - FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-...

K934265 is an FDA 510(k) clearance for FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-..., manufactured by Flexmedics. The device is a Class 1 Dental device with product code DZC cleared through the Traditional 510(k) pathway after a 143-day FDA review.

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

FDA 510(k) Submission Details - K934265

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.

DZC Device Classification - Class 1, General Controls

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.