Cleared Abbreviated

PERFECT TISSUE CONTOURING SYSTEM II

K071632 · Coltene/Whaledent, Inc. · Dental
Oct 2007
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K071632 is an FDA 510(k) clearance for the PERFECT TISSUE CONTOURING SYSTEM II, a Unit, Electrosurgical, And Accessories, Dental (Class II — Special Controls, product code EKZ), submitted by Coltene/Whaledent, Inc. (Cuyahoga Falls, US). The FDA issued a Cleared decision on October 18, 2007, 126 days after receiving the submission on June 14, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.4920.

Submission Details

510(k) Number K071632 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2007
Decision Date October 18, 2007
Days to Decision 126 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKZ — Unit, Electrosurgical, And Accessories, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4920