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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name toothbrush, manual
510(k) Number K000290
Device Name LAZERSMILE, LAZERWHITE
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 Number872.6855
Classification Product Code
EFW  
Date Received01/31/2000
Decision Date 04/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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