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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 K990219
Device Name MODIFICATION OF MILLENNIUM
Applicant
Biolase Technology, Inc.
981 Calle Amanecer
Clemente,  CA  92673
Applicant Contact ANDREW KIMMEL
Correspondent
Biolase Technology, Inc.
981 Calle Amanecer
Clemente,  CA  92673
Correspondent Contact ANDREW KIMMEL
Regulation Number872.4120
Classification Product Code
MXF  
Date Received01/22/1999
Decision Date 02/24/1999
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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