Cleared Traditional

DUOMAT 3 AMALGAMATOR (K914340) - FDA 510(k) Clearance

Class I Dental device.

K914340 · Degussa AG · Dental device
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Nov 1991
Decision
47d
Days
Class 1
Risk

K914340 is an FDA 510(k) clearance for the DUOMAT 3 AMALGAMATOR. Classified as Amalgamator, Dental, Ac-powered (product code EFD), Class I - General Controls.

Submitted by Degussa AG (South Plainfield, US). The FDA issued a Cleared decision on November 13, 1991 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3100 - 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 Degussa AG devices

Submission Details

510(k) Number K914340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1991
Decision Date November 13, 1991
Days to Decision 47 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 127d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFD Amalgamator, Dental, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3100
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.