Cleared Traditional

K973636 - MCS-MEDICATED CANAL SEALER
(FDA 510(k) Clearance)

K973636 · Dr. Howard Martin, P.A. · Dental device

Jul 1998

Decision

306d

Days

Class 2

Risk

K973636 is an FDA 510(k) clearance for the MCS-MEDICATED CANAL SEALER. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Dr. Howard Martin, P.A. (Frederick, US). The FDA issued a Cleared decision on July 27, 1998, 306 days after receiving the submission on September 24, 1997.

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

Submission Details

510(k) Number	K973636 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 24, 1997
Decision Date	July 27, 1998
Days to Decision	306 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement