Cleared Traditional

K955285 - GALLOY
(FDA 510(k) Clearance)

K955285 · Southern Dental Industries, Inc. · Dental device

Jan 1996

Decision

68d

Days

Class 2

Risk

K955285 is an FDA 510(k) clearance for the GALLOY. This device is classified as a Alloy, Amalgam (Class II - Special Controls, product code EJJ).

Submitted by Southern Dental Industries, Inc. (San Francisco, US). The FDA issued a Cleared decision on January 24, 1996, 68 days after receiving the submission on November 17, 1995.

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

Submission Details

510(k) Number	K955285 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 17, 1995
Decision Date	January 24, 1996
Days to Decision	68 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement