Cleared Traditional

K923837 - DIMPLED MULTI MODULUS ARCH WIRE

K923837 is an FDA 510(k) clearance for DIMPLED MULTI MODULUS ARCH WIRE, manufactured by Ultimate Wireforms, Inc.. The device is a Class 1 Dental device with product code DZC cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K923837 · Ultimate Wireforms, Inc. · Dental device
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Mar 1993
Decision
244d
Days
Class 1
Risk

K923837 is an FDA 510(k) clearance for the DIMPLED MULTI MODULUS ARCH WIRE. Classified as Wire, Orthodontic (product code DZC), Class I - General Controls.

Submitted by Ultimate Wireforms, Inc. (Terryville, US). The FDA issued a Cleared decision on March 31, 1993 after a review of 244 days - an extended review cycle.

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 Ultimate Wireforms, Inc. devices

FDA 510(k) Submission Details - K923837

510(k) Number K923837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1992
Decision Date March 31, 1993
Days to Decision 244 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
117d slower than avg
Panel avg: 127d · This submission: 244d
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.