Cleared Traditional

DENTIMEDIC DENTAL EMERGENCY KIT (K861681) - FDA 510(k) Clearance

Class I Dental device.

K861681 · Dentimedic · Dental device
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Sep 1986
Decision
145d
Days
Class 1
Risk

K861681 is an FDA 510(k) clearance for the DENTIMEDIC DENTAL EMERGENCY KIT. Classified as Zinc Oxide Eugenol (product code EMB), Class I - General Controls.

Submitted by Dentimedic (Pocomoke City, US). The FDA issued a Cleared decision on September 23, 1986 after a review of 145 days - within the typical 510(k) review window.

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: 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 Dentimedic devices

Submission Details

510(k) Number K861681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1986
Decision Date September 23, 1986
Days to Decision 145 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 127d · This submission: 145d
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.