Cleared Traditional

PEMACO BITE WAX SHEETS (K895563) - FDA 510(k) Clearance

Class I Dental device.

K895563 · Pemaco, Inc. · Dental device
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Nov 1989
Decision
61d
Days
Class 1
Risk

K895563 is an FDA 510(k) clearance for the PEMACO BITE WAX SHEETS. 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 November 6, 1989 after a review of 61 days - a notably fast clearance 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: 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 Pemaco, Inc. devices

Submission Details

510(k) Number K895563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1989
Decision Date November 06, 1989
Days to Decision 61 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 127d · This submission: 61d
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.