DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM— 510(k) K051660

Name: FDA 510(k) clearance K051660
Creator: U.S. Food and Drug Administration
Published: 2005-08-04

Substantially Equivalent

Coltene/Whaledent, Inc.

FDA 510(k) clearance K051660 for DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM, Substantially Equivalent on 2005-08-04. Applicant: Coltene/Whaledent, Inc.. Device class: 2.

Clearance details

Applicant: Coltene/Whaledent, Inc.
Product code: Code KMH
Device class: Class 2
Regulation: 21 CFR 880.6870
Advisory panel: General Hospital
Date received: 2005-06-22
Decision date: 2005-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cuyahoga Falls, OH, US

Download summary PDF View on FDA.gov ↗

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