Cleared Traditional

ULTRAFIL-LT (GUTTA PERCHA)

K850863 · The Hygenic Corp. · Dental
Apr 1985
Decision
46d
Days
Class 1
Risk

About This 510(k) Submission

K850863 is an FDA 510(k) clearance for the ULTRAFIL-LT (GUTTA PERCHA), a Gutta-percha (Class I — General Controls, product code EKM), submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on April 16, 1985, 46 days after receiving the submission on March 1, 1985. This device falls under the Dental review panel. Regulated under 21 CFR 872.3850.

Submission Details

510(k) Number K850863 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 1985
Decision Date April 16, 1985
Days to Decision 46 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EKM — Gutta-percha
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.3850