Cleared Traditional

K854529 - INLAY WAX REGULAR

K854529 is an FDA 510(k) clearance for INLAY WAX REGULAR, manufactured by The Hygenic Corp.. The device is a Class 1 Dental device with product code EGD cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K854529 · The Hygenic Corp. · Dental device
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Mar 1986
Decision
117d
Days
Class 1
Risk

K854529 is an FDA 510(k) clearance for the INLAY WAX REGULAR. Classified as Wax, Dental, Intraoral (product code EGD), Class I - General Controls.

Submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on March 10, 1986 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6890 - 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 The Hygenic Corp. devices

FDA 510(k) Submission Details - K854529

510(k) Number K854529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1985
Decision Date March 10, 1986
Days to Decision 117 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 127d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

EGD Device Classification - Class 1, General Controls

Product Code EGD Wax, Dental, Intraoral
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6890
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.