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510(k) K022803

Device
WATERLASE FOR APICOECTOMY
Applicant
BIOLASE TECHNOLOGY, INC.
510(k) number
K022803
Product code
MXF  
Decision
Substantially Equivalent (SESE)
Decision date
2003-02-03
Date received
2002-08-23
Regulation
872.4120
Classification name
System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
IOANA M RIZOIU
Address
981 Calle Amanecer Clemente CA US 92673 92673

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MXF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K013908WATERLASE MILLENNIUMBiolase Technology, Inc.2002-02-12
K012511WATERLASE MILLENNIUMBiolase Technology, Inc.2002-01-18
K990908MILLENNIUMEndo Technic Corp.1999-05-27
K990219MODIFICATION OF MILLENNIUMBiolase Technology, Inc.1999-02-24

Legacy Summary#

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FDA Review#

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