FDA · official record K051573Substantially Equivalent

TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)

Name: TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) — FDA K051573
Creator: Dr. Howard Martin, P.A.
Keywords: TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE), TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE), K051573, EKM, FDA

United StatesEKMDr. Howard Martin, P.A.

Verified

Official record identity

FDA application number: K051573
Decision date: June 26, 2006
Published decision: Substantially Equivalent

Classification

Product code: EKM

Published parties

Applicant: Dr. Howard Martin, P.A.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2005-06-14
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.3850

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.