Cleared Traditional

K073698 - SECURE (FDA 510(k) Clearance)

K073698 · Parkell, Inc. · Dental device

Mar 2008

Decision

79d

Days

Class 2

Risk

K073698 is an FDA 510(k) clearance for the SECURE. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on March 19, 2008, 79 days after receiving the submission on December 31, 2007.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K073698 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 31, 2007
Decision Date	March 19, 2008
Days to Decision	79 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF