Cleared Traditional

COATED ORTHODONTIC DEVICES (K931631) - FDA 510(k) Clearance

Class I Dental device.

K931631 · Wonder Wire · Dental device
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Jul 1993
Decision
117d
Days
Class 1
Risk

K931631 is an FDA 510(k) clearance for the COATED ORTHODONTIC DEVICES. Classified as Wire, Orthodontic (product code DZC), Class I - General Controls.

Submitted by Wonder Wire (Wyomissing, US). The FDA issued a Cleared decision on July 28, 1993 after a review of 117 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 Wonder Wire devices

Submission Details

510(k) Number K931631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1993
Decision Date July 28, 1993
Days to Decision 117 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
10d faster than avg
Panel avg: 127d · This submission: 117d
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.