Cleared Traditional

K923974 - SILIMAT PLUS (FDA 510(k) Clearance)

K923974 · Ivoclar North America, Inc. · Dental device

Oct 1992

Decision

60d

Days

Class 1

Risk

K923974 is an FDA 510(k) clearance for the SILIMAT PLUS. This device is classified as a Amalgamator, Dental, Ac-powered (Class I - General Controls, product code EFD).

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on October 6, 1992, 60 days after receiving the submission on August 7, 1992.

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

Submission Details

510(k) Number	K923974 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 07, 1992
Decision Date	October 06, 1992
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement