Cleared Traditional

COMPOTHIXO

K111465 · Kerrhawe SA · Dental
Jul 2012
Decision
426d
Days
Class 1
Risk

About This 510(k) Submission

K111465 is an FDA 510(k) clearance for the COMPOTHIXO, a Instruments, Dental Hand (Class I — General Controls, product code DZN), submitted by Kerrhawe SA (Orange, US). The FDA issued a Cleared decision on July 25, 2012, 426 days after receiving the submission on May 26, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K111465 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2011
Decision Date July 25, 2012
Days to Decision 426 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZN — Instruments, Dental Hand
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565