Cleared Traditional

K861681 - DENTIMEDIC DENTAL EMERGENCY KIT

K861681 is an FDA 510(k) clearance for DENTIMEDIC DENTAL EMERGENCY KIT, manufactured by Dentimedic. The device is a Class 1 Dental device with product code EMB cleared through the Traditional 510(k) pathway after a 145-day FDA review.

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.

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FDA 510(k) Submission Details - K861681

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
17d slower than avg
Panel avg: 128d · This submission: 145d
Pathway characteristics
Predicate-based equivalence.

EMB Device Classification - Class 1, General Controls

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.