FDA 510(k) Application Details - K990219

Device Classification Name System,Dental,Hydrokinetic,Carries Removal & Cavity Preparation

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510(K) Number K990219
Device Name System,Dental,Hydrokinetic,Carries Removal & Cavity Preparation
Applicant BIOLASE TECHNOLOGY, INC.
981 CALLE AMANECER
SAN CLEMENTE, CA 92673 US
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Contact ANDREW KIMMEL
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Regulation Number 872.4120

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Classification Product Code MXF
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Date Received 01/22/1999
Decision Date 02/24/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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