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FDA 510(k)

Smile Dx®

K-Number: K242437 · 2025-05-14

ApplicantCube Click, Inc.
Decision Date2025-05-14
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Smile Dx® is the device name listed in this FDA 510(k) record. The listed applicant is Cube Click, Inc.. It received FDA 510(k) clearance on 2025-05-14 under 510(k) number K242437. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smile Dx®?

Smile Dx® is a medical device that received FDA 510(k) clearance on 2025-05-14. The listed applicant is Cube Click, Inc.. The 510(k) number is K242437.

When did Smile Dx® receive FDA 510(k) clearance?

Smile Dx® received FDA 510(k) clearance on 2025-05-14, under 510(k) number K242437.

Who is the listed applicant for Smile Dx®?

The FDA 510(k) record lists Cube Click, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smile Dx®?

The FDA product code for Smile Dx® is MYN.

Related Devices (Code: MYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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