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FDA 510(k) Application Details - K213482
Device Classification Name
Caries Detector, Laser Light, Transmission
More FDA Info for this Device
510(K) Number
K213482
Device Name
Caries Detector, Laser Light, Transmission
Applicant
D4D Technologies, LLC
2920 Telecom Parkway, Suite 100
Richardson, TX 75082 US
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Contact
Eddie Anderson
Other 510(k) Applications for this Contact
Regulation Number
872.1745
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Classification Product Code
NTK
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More FDA Info for this Product Code
Date Received
10/29/2021
Decision Date
04/29/2022
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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