Cleared Traditional

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

K914340 · Degussa AG · Dental device

Nov 1991

Decision

47d

Days

Class 1

Risk

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

Submitted by Degussa AG (South Plainfield, US). The FDA issued a Cleared decision on November 13, 1991, 47 days after receiving the submission on September 27, 1991.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3100.

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