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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
510(k) Number K012511
Device Name WATERLASE MILLENNIUM
Applicant
Biolase Technology, Inc.
981 Calle Amanecer
Clemente,  CA  92673
Applicant Contact IOANA M RIZOIU
Correspondent
Biolase Technology, Inc.
981 Calle Amanecer
Clemente,  CA  92673
Correspondent Contact IOANA M RIZOIU
Regulation Number872.4120
Classification Product Code
MXF  
Subsequent Product Code
GEX  
Date Received08/06/2001
Decision Date 01/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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