Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Smartooth Co., Ltd.. It received FDA 510(k) clearance on 2024-05-01 under approval 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. It is manufactured by Smartooth Co., Ltd.. The 510(k) number is K231722.

When was SmarTooth approved by the FDA?

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

What company makes SmarTooth?

SmarTooth is manufactured by Smartooth Co., Ltd..

What is the FDA product code for SmarTooth?

The FDA product code for SmarTooth is NBL.

Related Devices (Code: NBL)

K150672VistaCam iX ProofDurr Dental AG K170822Electronic Caries DetectorOrtek Therapeutics, Inc. K171007Fluorescence ModeCarl Zeiss Suzhou Co., Ltd. K183471IC-WHCD100 (Inspire)Good Doctors Co., Ltd. K221249L1P-1F (TRIOS 5)3Shape TRIOS A/S K223470C50Sopro

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.

↑