Smile Dx®— 510(k) K242437
Substantially EquivalentCube Click, Inc.
FDA 510(k) clearance K242437 for Smile Dx®, Substantially Equivalent on 2025-05-14. Applicant: Cube Click, Inc.. Device class: 2.
Clearance details
- Applicant
- Cube Click, Inc.
- Product code
- Code MYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.2070
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code MYN
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