Cleared Abbreviated

K071632 - PERFECT TISSUE CONTOURING SYSTEM II

K071632 is an FDA 510(k) clearance for PERFECT TISSUE CONTOURING SYSTEM II, manufactured by Coltene/Whaledent, Inc.. The device is a Class 2 Dental device with product code EKZ cleared through the Abbreviated 510(k) pathway after a 126-day FDA review.

K071632 · Coltene/Whaledent, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
126d
Days
Class 2
Risk

K071632 is an FDA 510(k) clearance for the PERFECT TISSUE CONTOURING SYSTEM II. Classified as Unit, Electrosurgical, And Accessories, Dental (product code EKZ), Class II - Special Controls.

Submitted by Coltene/Whaledent, Inc. (Cuyahoga Falls, US). The FDA issued a Cleared decision on October 18, 2007 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4920 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K071632

510(k) Number K071632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 128d · This submission: 126d
Pathway characteristics
Standards-based clearance path.

EKZ Device Classification - Class 2, Special Controls

Product Code EKZ Unit, Electrosurgical, And Accessories, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EKZ Unit, Electrosurgical, And Accessories, Dental

All 16
Devices cleared under the same product code (EKZ) and FDA review panel - the closest regulatory comparables to K071632.
Root ZX3
K213477 · J. Morita USA, Inc. · Aug 2022
THE FUGO BLADE FOR DENTISTRY
K063468 · Medisurg , Ltd. · Apr 2007
MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT
K052622 · Macan Engineering Co. · Dec 2005
MC6A
K050735 · Macan Engineering Co. · May 2005
X O ODONTOSURGE 4
K023672 · Xo Care A/S · Apr 2003
BONART ART-E1 ELECTROSURGERY UNIT
K020080 · Diagnostic Data, Inc. · Feb 2002