Cleared Traditional

K923306 - HEALTHPAK UTILITY SOX BARRIERS (FDA 510(k) Clearance)

Class I Dental device.

K923306 · Healthpak, Inc. · Dental device
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Aug 1992
Decision
89d
Days
Class 1
Risk

K923306 is an FDA 510(k) clearance for the HEALTHPAK UTILITY SOX BARRIERS. Classified as Chair, Dental, With Operative Unit (product code KLC), Class I - General Controls.

Submitted by Healthpak, Inc. (Chicago, US). The FDA issued a Cleared decision on August 5, 1992 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6250 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Healthpak, Inc. devices

Submission Details

510(k) Number K923306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1992
Decision Date August 05, 1992
Days to Decision 89 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
38d faster than avg
Panel avg: 127d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KLC Chair, Dental, With Operative Unit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6250
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.