Cleared Traditional

INTRAORAL DENTAL WAX (K910676) - FDA 510(k) Clearance

Class I Dental device.

K910676 · Pemaco, Inc. · Dental device
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Aug 1991
Decision
187d
Days
Class 1
Risk

K910676 is an FDA 510(k) clearance for the INTRAORAL DENTAL WAX. Classified as Wax, Dental, Intraoral (product code EGD), Class I - General Controls.

Submitted by Pemaco, Inc. (Fenton, US). The FDA issued a Cleared decision on August 21, 1991 after a review of 187 days - an extended review cycle.

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 Pemaco, Inc. devices

Submission Details

510(k) Number K910676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1991
Decision Date August 21, 1991
Days to Decision 187 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 127d · This submission: 187d
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.