PERFECT TISSUE CONTOURING SYSTEM II— 510(k) K071632

Name: FDA 510(k) clearance K071632
Creator: U.S. Food and Drug Administration
Published: 2007-10-18

Substantially Equivalent

Coltene/Whaledent, Inc.

FDA 510(k) clearance K071632 for PERFECT TISSUE CONTOURING SYSTEM II, Substantially Equivalent on 2007-10-18. Applicant: Coltene/Whaledent, Inc.. Device class: 2.

Clearance details

Applicant: Coltene/Whaledent, Inc.
Product code: Code EKZ
Device class: Class 2
Regulation: 21 CFR 872.4920
Advisory panel: Dental
Date received: 2007-06-14
Decision date: 2007-10-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Cuyahoga Falls, OH, US

Download summary PDF View on FDA.gov ↗

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