ULTRAFIL-LT (GUTTA PERCHA)— 510(k) K850863

Substantially Equivalent

The Hygenic Corp.

FDA 510(k) clearance K850863 for ULTRAFIL-LT (GUTTA PERCHA), Substantially Equivalent on 1985-04-16. Applicant: The Hygenic Corp.. Device class: 1.

Clearance details

Applicant: The Hygenic Corp.
Product code: Code EKM
Device class: Class 1
Regulation: 21 CFR 872.3850
Advisory panel: Dental
Date received: 1985-03-01
Decision date: 1985-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, 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 The Hygenic Corp.

K954990 — DENTAL DAM1996-01-26
K930764 — ENDO-ICE-PULP TESTER-THERMAL1993-05-27
K905418 — GATES GLIDDEN DRILLS1991-07-25
K911225 — TRAY DOUGH1991-04-17
K905640 — SOLID CORE GUTTA PERCHA CARRIER1991-03-05

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