FDA.report

510(k) K231722

Device
SmarTooth
Applicant
Smartooth Co., Ltd.
510(k) number
K231722
Product code
NBL
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-01
Date received
2023-06-13
Regulation
872.1745
Classification name
Laser, Fluorescence Caries Detection
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Seohyun Yoon
Address
509, 10, Noryangjin-Ro, Dongjak-Gu Seoul KR 06938 06938

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
08809941490121SmartoothSmartooth Co., Ltd.2024-07-22

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