Cleared Traditional

MERCURY DISP. CAPSULE (K781243) - FDA 510(k) Clearance

Class I Dental device.

K781243 · Lee Pharmaceuticals · Dental device
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Sep 1978
Decision
100d
Days
Class 1
Risk

K781243 is an FDA 510(k) clearance for the MERCURY DISP. CAPSULE. Classified as Capsule, Dental, Amalgam (product code DZS), Class I - General Controls.

Submitted by Lee Pharmaceuticals (Mchenry, US). The FDA issued a Cleared decision on September 20, 1978 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3110 - 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 Lee Pharmaceuticals devices

Submission Details

510(k) Number K781243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1978
Decision Date September 20, 1978
Days to Decision 100 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 127d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DZS Capsule, Dental, Amalgam
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3110
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.