Cleared Traditional

TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)

K051573 · Dr. Howard Martin, P.A. · Dental

Jun 2006

Decision

377d

Days

Class 1

Risk

About This 510(k) Submission

K051573 is an FDA 510(k) clearance for the TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE), 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 June 26, 2006, 377 days after receiving the submission on June 14, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3850.

Submission Details

510(k) Number	K051573 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 14, 2005
Decision Date	June 26, 2006
Days to Decision	377 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement