Cleared Traditional

K093587 - DENTAL MERCURY
(FDA 510(k) Clearance)

K093587 · Dmg USA, Inc. · Dental

Jan 2010

Decision

63d

Days

Class 2

Risk

K093587 is an FDA 510(k) clearance for the DENTAL MERCURY. This device is classified as a Mercury (Class II — Special Controls, product code ELY).

Submitted by Dmg USA, Inc. (Attleboro, US). The FDA issued a Cleared decision on January 21, 2010, 63 days after receiving the submission on November 19, 2009.

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

Submission Details

510(k) Number	K093587 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 19, 2009
Decision Date	January 21, 2010
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF