Cleared Traditional

ENDOSOLV E

K980633 · Specialites Septodont · Dental
May 1998
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K980633 is an FDA 510(k) clearance for the ENDOSOLV E, a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on May 1, 1998, 71 days after receiving the submission on February 19, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K980633 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1998
Decision Date May 01, 1998
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KIF — Resin, Root Canal Filling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3820