Cleared Traditional

K923838 - THE ULTIMATE RCS ARCH WIRE

K923838 is an FDA 510(k) clearance for THE ULTIMATE RCS 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 127-day FDA review.

K923838 · Ultimate Wireforms, Inc. · Dental device
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Dec 1992
Decision
127d
Days
Class 1
Risk

K923838 is an FDA 510(k) clearance for the THE ULTIMATE RCS 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 December 4, 1992 after a review of 127 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 Ultimate Wireforms, Inc. devices

FDA 510(k) Submission Details - K923838

510(k) Number K923838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1992
Decision Date December 04, 1992
Days to Decision 127 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
At panel average
Panel avg: 127d · This submission: 127d
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.