Cleared Traditional

ALASTIK (K933501) - FDA 510(k) Clearance

Class I Dental device.

K933501 · Unitek Corp. · Dental device
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Apr 1994
Decision
283d
Days
Class 1
Risk

K933501 is an FDA 510(k) clearance for the ALASTIK. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Unitek Corp. (Monrovia, US). The FDA issued a Cleared decision on April 28, 1994 after a review of 283 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.

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Submission Details

510(k) Number K933501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1993
Decision Date April 28, 1994
Days to Decision 283 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
156d slower than avg
Panel avg: 127d · This submission: 283d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EJF Bracket, Metal, 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.