Cleared Traditional

SET CANAL SEALER PASTE

K862129 · Endo Technic Corp. · Dental
Jul 1986
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K862129 is an FDA 510(k) clearance for the SET CANAL SEALER PASTE, a Gutta-percha (Class I — General Controls, product code EKM), submitted by Endo Technic Corp. (Natick, US). The FDA issued a Cleared decision on July 22, 1986, 48 days after receiving the submission on June 4, 1986. This device falls under the Dental review panel. Regulated under 21 CFR 872.3850.

Submission Details

510(k) Number K862129 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 1986
Decision Date July 22, 1986
Days to Decision 48 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