Cleared Traditional

K930094 - AUKUSLEEVE (FDA 510(k) Clearance)

Class I Dental device.

K930094 · Aukland Medical Plastics, Inc. · Dental device
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Oct 1993
Decision
285d
Days
Class 1
Risk

K930094 is an FDA 510(k) clearance for the AUKUSLEEVE. Classified as Handle, Instrument, Dental (product code EJB), Class I - General Controls.

Submitted by Aukland Medical Plastics, Inc. (Cary, US). The FDA issued a Cleared decision on October 20, 1993 after a review of 285 days - an extended review cycle.

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 Aukland Medical Plastics, Inc. devices

Submission Details

510(k) Number K930094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1993
Decision Date October 20, 1993
Days to Decision 285 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
158d slower than avg
Panel avg: 127d · This submission: 285d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EJB Handle, Instrument, Dental
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.