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FDA 510(k)

SmarTooth

K-Number: K231722 · 2024-05-01

ApplicantSmartooth Co., Ltd.
Decision Date2024-05-01
Product CodeNBL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SmarTooth is the device name listed in this FDA 510(k) record. The listed applicant is Smartooth Co., Ltd.. It received FDA 510(k) clearance on 2024-05-01 under 510(k) number K231722. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmarTooth?

SmarTooth is a medical device that received FDA 510(k) clearance on 2024-05-01. The listed applicant is Smartooth Co., Ltd.. The 510(k) number is K231722.

When did SmarTooth receive FDA 510(k) clearance?

SmarTooth received FDA 510(k) clearance on 2024-05-01, under 510(k) number K231722.

Who is the listed applicant for SmarTooth?

The FDA 510(k) record lists Smartooth Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmarTooth?

The FDA product code for SmarTooth is NBL.

Related Devices (Code: NBL)

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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