Cleared Traditional

ISODAN

K010415 · Specialites Septodont · Dental
Jul 2001
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K010415 is an FDA 510(k) clearance for the ISODAN, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on July 23, 2001, 161 days after receiving the submission on February 12, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K010415 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 2001
Decision Date July 23, 2001
Days to Decision 161 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200