Cleared Traditional

K973088 - PLS-96P
(FDA 510(k) Clearance)

K973088 · Southern Dental Industries, Inc. · Dental device

Oct 1997

Decision

46d

Days

Class 2

Risk

K973088 is an FDA 510(k) clearance for the PLS-96P. 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 October 3, 1997, 46 days after receiving the submission on August 18, 1997.

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

Submission Details

510(k) Number	K973088 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 18, 1997
Decision Date	October 03, 1997
Days to Decision	46 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement