ANTIBACTERIAL GUTTA PERCHA— 510(k) K971641

Name: FDA 510(k) clearance K971641
Creator: U.S. Food and Drug Administration
Published: 1997-07-21

Substantially Equivalent

Dr. Howard Martin, P.A.

FDA 510(k) clearance K971641 for ANTIBACTERIAL GUTTA PERCHA, Substantially Equivalent on 1997-07-21. Applicant: Dr. Howard Martin, P.A.. Device class: 1.

Clearance details

Applicant: Dr. Howard Martin, P.A.
Product code: Code EKM
Device class: Class 1
Regulation: 21 CFR 872.3850
Advisory panel: Dental
Date received: 1997-05-02
Decision date: 1997-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frederick, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKM

view all

K073369 — EI DOWNPAK BARRIER SLEEVES2008-02-27
K070246 — DOWN PAK2007-02-16
K051573 — TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)2006-06-26
K042870 — ENDO TWINN2005-01-11
K023819 — FIBERFILL SGP2003-03-26

More clearances from Dr. Howard Martin, P.A.

view all

K973636 — MCS-MEDICATED CANAL SEALER1998-07-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.