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FDA 510(k)

STR8 Clear Aligner

K-Number: K223141 · 2023-04-24

ApplicantStr8 Oral Care
Decision Date2023-04-24
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STR8 Clear Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Str8 Oral Care. It received FDA 510(k) clearance on 2023-04-24 under 510(k) number K223141. 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 STR8 Clear Aligner?

STR8 Clear Aligner is a medical device that received FDA 510(k) clearance on 2023-04-24. The listed applicant is Str8 Oral Care. The 510(k) number is K223141.

When did STR8 Clear Aligner receive FDA 510(k) clearance?

STR8 Clear Aligner received FDA 510(k) clearance on 2023-04-24, under 510(k) number K223141.

Who is the listed applicant for STR8 Clear Aligner?

The FDA 510(k) record lists Str8 Oral Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STR8 Clear Aligner?

The FDA product code for STR8 Clear Aligner 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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