Cleared Traditional

EUGENOL USP (K862745) - FDA 510(k) Clearance

Class I Dental device.

K862745 · E&D Dental Manufacturing Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1986
Decision
10d
Days
Class 1
Risk

K862745 is an FDA 510(k) clearance for the EUGENOL USP. Classified as Zinc Oxide Eugenol (product code EMB), Class I - General Controls.

Submitted by E&D Dental Manufacturing Co. (Hillside, US). The FDA issued a Cleared decision on July 31, 1986 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 E&D Dental Manufacturing Co. devices

Submission Details

510(k) Number K862745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1986
Decision Date July 31, 1986
Days to Decision 10 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 127d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EMB Zinc Oxide Eugenol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3275
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.