510(k) K242437
- Device
- Smile Dx®
- Applicant
- Cube Click, Inc.
- 510(k) number
- K242437
- Product code
- MYN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-14
- Date received
- 2024-08-16
- 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
Related Records
Applicant Contact
- Contact
- Richard Ricci
- Address
- 105 E. 34 St. Suite 231 New York NY US 10016 10016
FDA Registration Numbers
- 3014398772
- 3019544554
- 3021907554
- 3038187462
- 3022719380
- 3024891354
- 3038172231
- 1226003
- 9611992
- 3005383085
- 3012035824
- 3025110425
- 3021887566
- 3005496266
- 3026970882
- 3029904428
- 3043237021
- 3026753394
- 8020825
- 3010300212
- 3005739655
- 3008693672
- 3032960222
- 3029956998
- 3032116890
- 3005156333
- 3014661828
- 3017840913
Source Documents
Other 510(k) Records For Product Code MYN
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|---|---|---|---|
| K252953 | Velmeni for Dentists (V4D) Endo-Perio | Velmeni, Inc. | 2026-05-11 |
| K251934 | qXR-Detect | Qure.Ai Technologies | 2026-01-16 |
| K252934 | Diagnocat | DGNCT, LLC | 2026-01-15 |
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| K250264 | SugarBug (1.x) | Bench7, Inc. | 2025-11-07 |
| K251002 | Videa Dental AI | Videahealth, Inc. | 2025-09-19 |
| K250753 | VELMENI for DENTISTS (V4D) | Velmeni, Inc. | 2025-09-02 |
| K243234 | Second Opinion® CS | Pearl, Inc. | 2025-06-12 |
| K243893 | Second Opinion® Pediatric | Pearl, Inc. | 2025-05-05 |
| K243239 | Lung AI (LAI001) | Exo, Inc. | 2025-04-24 |
| K242600 | Second Opinion Periapical Radiolucency Contours | Pearl, Inc. | 2025-04-11 |
| K243831 | Rayvolve LN | AZmed | 2025-03-26 |
| K241725 | Better Diagnostics Caries Assist (BDCA) Version 1.0 | Better Diagnostics AI Corp. | 2025-03-11 |