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FDA 510(k)

Straight T Clear Dental Aligner

K-Number: K201450 · 2020-09-10

ApplicantStraight T, Inc.
Decision Date2020-09-10
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straight T Clear Dental Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Straight T, Inc.. It received FDA 510(k) clearance on 2020-09-10 under 510(k) number K201450. 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 Straight T Clear Dental Aligner?

Straight T Clear Dental Aligner is a medical device that received FDA 510(k) clearance on 2020-09-10. The listed applicant is Straight T, Inc.. The 510(k) number is K201450.

When did Straight T Clear Dental Aligner receive FDA 510(k) clearance?

Straight T Clear Dental Aligner received FDA 510(k) clearance on 2020-09-10, under 510(k) number K201450.

Who is the listed applicant for Straight T Clear Dental Aligner?

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

What is the FDA product code for Straight T Clear Dental Aligner?

The FDA product code for Straight T Clear Dental Aligner is NXC.

Related Clinical Trials

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.

NCT07628491Effect of Finishing Clear Aligner Marginal Termination Design (Supragingival vs Juxtagingival) on Aligner Color Stability After 14 Days of Wear: A Split-Mouth StudyCOMPLETEDNCT07642037Marginal Biofilm Distribution and Periodontal Response to Supragingival and Juxtagingival Aligner DesignsCOMPLETEDNCT05573308Optimizing Orthodontic Appliances Efficiency With Remote Dental Monitoring and Artificial Intelligence AlgorithmsRECRUITINGNCT07290790A Prospective Multicenter Clinical Investigation Evaluating the Accuracy of the Trimline Design When Treated With SureSmile® Aligners.RECRUITINGNCT07420777Investigate the Effectiveness of 3D-printed Shape Memory Aligners in the Treatment of Anterior Open BiteRECRUITINGNCT07533058Influence of Finishing Clear Aligner Marginal Termination Design on Subgingival Periodontal Microbiota During Orthodontic Treatment: A Split-Mouth Study.COMPLETED

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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