Cleared Traditional

K872622 - ORTHODONTIC ARCH

K872622 is an FDA 510(k) clearance for ORTHODONTIC ARCH, manufactured by Wonder Wire. The device is a Class 1 Dental device with product code EJZ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K872622 · Wonder Wire · Dental device
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Oct 1987
Decision
95d
Days
Class 1
Risk

K872622 is an FDA 510(k) clearance for the ORTHODONTIC ARCH. Classified as Knife, Margin Finishing, Operative (product code EJZ), Class I - General Controls.

Submitted by Wonder Wire (Wyomissing, US). The FDA issued a Cleared decision on October 9, 1987 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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

FDA 510(k) Submission Details - K872622

510(k) Number K872622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1987
Decision Date October 09, 1987
Days to Decision 95 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 127d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

EJZ Device Classification - Class 1, General Controls

Product Code EJZ Knife, Margin Finishing, Operative
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.