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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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More FDA Info for this Product Code
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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