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FDA 510(k)

Toothsi, Smilealigners

K-Number: K223338 · 2023-02-09

ApplicantMakeo Healthcare Technologies Private Limited
Decision Date2023-02-09
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Toothsi, Smilealigners is the device name listed in this FDA 510(k) record. The listed applicant is Makeo Healthcare Technologies Private Limited. It received FDA 510(k) clearance on 2023-02-09 under 510(k) number K223338. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Toothsi, Smilealigners?

Toothsi, Smilealigners is a medical device that received FDA 510(k) clearance on 2023-02-09. The listed applicant is Makeo Healthcare Technologies Private Limited. The 510(k) number is K223338.

When did Toothsi, Smilealigners receive FDA 510(k) clearance?

Toothsi, Smilealigners received FDA 510(k) clearance on 2023-02-09, under 510(k) number K223338.

Who is the listed applicant for Toothsi, Smilealigners?

The FDA 510(k) record lists Makeo Healthcare Technologies Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Toothsi, Smilealigners?

The FDA product code for Toothsi, Smilealigners is NXC.

Related Devices (Code: NXC)

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.

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) LimitedK250739Primeprint Direct AlignerDreve Dentamid GmbH

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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