MODIFICATION OF MILLENNIUM

System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation

BIOLASE TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Biolase Technology, Inc. with the FDA for Modification Of Millennium.

Pre-market Notification Details

Device IDK990219
510k NumberK990219
Device Name:MODIFICATION OF MILLENNIUM
ClassificationSystem, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
Applicant BIOLASE TECHNOLOGY, INC. 981 CALLE AMANECER San Clemente,  CA  92673
ContactAndrew Kimmel
CorrespondentAndrew Kimmel
BIOLASE TECHNOLOGY, INC. 981 CALLE AMANECER San Clemente,  CA  92673
Product CodeMXF  
CFR Regulation Number872.4120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-01-22
Decision Date1999-02-24
Summary:summary

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