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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
SAN CLEMENTE,  CA  92673
Applicant Contact IOANA M RIZOIU
Correspondent
BIOLASE TECHNOLOGY, INC.
981 CALLE AMANECER
SAN 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
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