GUTTA PERCHA POINTS— 510(k) K863638

Substantially Equivalent

Endodent, Inc.

FDA 510(k) clearance K863638 for GUTTA PERCHA POINTS, Substantially Equivalent on 1986-10-30. Applicant: Endodent, Inc.. Device class: 1.

Clearance details

Applicant: Endodent, Inc.
Product code: Code EKM
Device class: Class 1
Regulation: 21 CFR 872.3850
Advisory panel: Dental
Date received: 1986-09-17
Decision date: 1986-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monrovia, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKM

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 Endodent, Inc.

K863411 — GUTTA PERCHA1986-10-30
K830814 — POINT, PAPER ENDODONTIC1983-04-06

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