Cleared Traditional

K973548 - MERCURY DENTAL
(FDA 510(k) Clearance)

K973548 · Aleaciones Dentales Zeyco, S.A. DE C.V. · Dental device

Mar 1998

Decision

186d

Days

Class 2

Risk

K973548 is an FDA 510(k) clearance for the MERCURY DENTAL. This device is classified as a Mercury (Class II - Special Controls, product code ELY).

Submitted by Aleaciones Dentales Zeyco, S.A. DE C.V. (Guadalajara, MX). The FDA issued a Cleared decision on March 23, 1998, 186 days after receiving the submission on September 18, 1997.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3070.

Submission Details

510(k) Number	K973548 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 18, 1997
Decision Date	March 23, 1998
Days to Decision	186 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement