FDA · official record K022803Substantially Equivalent

WATERLASE FOR APICOECTOMY

Name: WATERLASE FOR APICOECTOMY — FDA K022803
Creator: Biolase Technology, Inc.
Keywords: WATERLASE FOR APICOECTOMY, WATERLASE FOR APICOECTOMY, K022803, MXF, FDA

United StatesMXFBiolase Technology, Inc.

Verified

Official record identity

FDA application number: K022803
Decision date: February 03, 2003
Published decision: Substantially Equivalent

Classification

Product code: MXF

Published parties

Applicant: Biolase Technology, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2002-08-23
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4120

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.