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FDA 510(k) Application Details - K170822
Device Classification Name
Laser,Fluorescence Caries Detection
More FDA Info for this Device
510(K) Number
K170822
Device Name
Laser,Fluorescence Caries Detection
Applicant
Ortek Therapeutics, Inc.
4 Expressway Plaza
Roslyn Heights, NY 11577 US
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Contact
Mitchell Goldberg
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Regulation Number
872.1745
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Classification Product Code
NBL
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More FDA Info for this Product Code
Date Received
03/20/2017
Decision Date
09/11/2017
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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