Cleared Traditional

K971641 - ANTIBACTERIAL GUTTA PERCHA
(FDA 510(k) Clearance)

K971641 · Dr. Howard Martin, P.A. · Dental device

Jul 1997

Decision

80d

Days

Class 1

Risk

K971641 is an FDA 510(k) clearance for the ANTIBACTERIAL GUTTA PERCHA. This device is classified as a Gutta-percha (Class I - General Controls, product code EKM).

Submitted by Dr. Howard Martin, P.A. (Frederick, US). The FDA issued a Cleared decision on July 21, 1997, 80 days after receiving the submission on May 2, 1997.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3850.

Submission Details

510(k) Number	K971641 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 02, 1997
Decision Date	July 21, 1997
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement