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)

Straight T Clear Dental Aligner

K-Number: K201450 · 2020-09-10

Decision Date2020-09-10
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straight T Clear Dental Aligner is a medical device manufactured by Straight T, Inc.. It received FDA 510(k) clearance on 2020-09-10 under approval 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. It is manufactured by Straight T, Inc.. The 510(k) number is K201450.

When was Straight T Clear Dental Aligner approved by the FDA?

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

What company makes Straight T Clear Dental Aligner?

Straight T Clear Dental Aligner is manufactured by Straight T, Inc..

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 Devices (Code: NXC)

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.