WATERLASE FOR APICOECTOMY— 510(k) K022803

Name: FDA 510(k) clearance K022803
Creator: U.S. Food and Drug Administration
Published: 2003-02-03

Substantially Equivalent

Biolase Technology, Inc.

FDA 510(k) clearance K022803 for WATERLASE FOR APICOECTOMY, Substantially Equivalent on 2003-02-03. Applicant: Biolase Technology, Inc.. Device class: 2.

Clearance details

Applicant: Biolase Technology, Inc.
Product code: Code MXF
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2002-08-23
Decision date: 2003-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clemente, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.