Cleared Traditional

PREMIUM FLEXI-TOUGH (K854530) - FDA 510(k) Clearance

Class I Dental device.

K854530 · The Hygenic Corp. · Dental device
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Mar 1986
Decision
111d
Days
Class 1
Risk

K854530 is an FDA 510(k) clearance for the PREMIUM FLEXI-TOUGH. 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 4, 1986 after a review of 111 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

Submission Details

510(k) Number K854530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1985
Decision Date March 04, 1986
Days to Decision 111 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 127d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.