Cleared Traditional

STAINLESS STEEL ARCHES REPACKER RELABETER (K933377) - FDA 510(k) Clearance

Class I Dental device.

K933377 · Highland Metals · Dental device
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Nov 1993
Decision
130d
Days
Class 1
Risk

K933377 is an FDA 510(k) clearance for the STAINLESS STEEL ARCHES REPACKER RELABETER. Classified as Wire, Orthodontic (product code DZC), Class I - General Controls.

Submitted by Highland Metals (San Jose, US). The FDA issued a Cleared decision on November 16, 1993 after a review of 130 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 Highland Metals devices

Submission Details

510(k) Number K933377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1993
Decision Date November 16, 1993
Days to Decision 130 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
3d slower than avg
Panel avg: 127d · This submission: 130d
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.