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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Caries Detector, Laser Light, Transmission
510(k) Number K213482
Device Name TIA Tip, Cariosity, Transillumination Accessory Tip
Applicant
D4D Technologies, LLC
2920 Telecom Parkway, Suite 100
Richardson,  TX  75082
Applicant Contact Eddie Anderson
Correspondent
D4D Technologies, LLC
2920 Telecom Parkway, Suite 100
Richardson,  TX  75082
Correspondent Contact Eddie Anderson
Regulation Number872.1745
Classification Product Code
NTK  
Date Received10/29/2021
Decision Date 04/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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