Cleared Traditional

K930094 - AUKUSLEEVE

K930094 is an FDA 510(k) clearance for AUKUSLEEVE, manufactured by Aukland Medical Plastics, Inc.. The device is a Class 1 Dental device with product code EJB cleared through the Traditional 510(k) pathway after a 285-day FDA review.

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

FDA 510(k) Submission Details - K930094

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.

EJB Device Classification - Class 1, General Controls

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.