Cleared Traditional

K915847 - AUTOMIX DENTAL AMALGAMATOR

K915847 is the FDA 510(k) clearance for AUTOMIX DENTAL AMALGAMATOR by Kerr Corporation (Danbury). It is a Class 1 Dental device (product code EFD) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K915847 · Kerr Corporation (Danbury) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
67d
Days
Class 1
Risk

K915847 is an FDA 510(k) clearance for the AUTOMIX DENTAL AMALGAMATOR. Classified as Amalgamator, Dental, Ac-powered (product code EFD), Class I - General Controls.

Submitted by Kerr Corporation (Danbury) (Romulus, US). The FDA issued a Cleared decision on March 2, 1992 after a review of 67 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 Kerr Corporation (Danbury) devices

Submission Details

510(k) Number K915847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1991
Decision Date March 02, 1992
Days to Decision 67 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 127d · This submission: 67d
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.

Regulatory Peers - EFD Amalgamator, Dental, Ac-powered

Devices cleared under the same product code (EFD) and FDA review panel - the closest regulatory comparables to K915847.
SILIMAT PLUS
K923974 · Ivoclar North America, Inc. · Oct 1992
DUOMAT 3 AMALGAMATOR
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DENTOMAT 3 AMALGAMATORS
K914339 · Degussa AG · Nov 1991
SILAMAT (AMALGAMATOR)
K901909 · Ivoclar North America, Inc. · Jun 1990
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K891064 · Espe GmbH (Us) · May 1989