FDA.report

510(k) K230144

Device
Denti.AI Detect
Applicant
Denti.Ai Technology, Inc.
510(k) number
K230144
Product code
MYN
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-06
Date received
2023-01-18
Regulation
892.2070
Classification name
Analyzer, Medical Image
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Lyudmila Tuzova
Address
99 Yorkville Ave., Suite 214 Toronto CA M5R3k5 M5R3k5

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code MYN

510(k)DeviceApplicantDecision date
K252953Velmeni for Dentists (V4D) Endo-PerioVelmeni, Inc.2026-05-11
K251934qXR-DetectQure.Ai Technologies2026-01-16
K252934DiagnocatDGNCT, LLC2026-01-15
K253009DS Core DetectDentsply Sirona, Inc.2026-01-07
K252086DTX Studio AssistNobel Biocare C/O Medicim NV2025-11-17
K250525Second Opinion® PanoramicPearl, Inc.2025-11-14
K250264SugarBug (1.x)Bench7, Inc.2025-11-07
K251002Videa Dental AIVideahealth, Inc.2025-09-19
K250753VELMENI for DENTISTS (V4D)Velmeni, Inc.2025-09-02
K243234Second Opinion® CSPearl, Inc.2025-06-12
K242437Smile Dx®Cube Click, Inc.2025-05-14
K243893Second Opinion® PediatricPearl, Inc.2025-05-05
K243239Lung AI (LAI001)Exo, Inc.2025-04-24
K242600Second Opinion Periapical Radiolucency ContoursPearl, Inc.2025-04-11
K243831Rayvolve LNAZmed2025-03-26