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FDA 510(k)

Angel Align System

K-Number: K171674 · 2018-01-19

ApplicantSmile Development Corp
Decision Date2018-01-19
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Angel Align System is a medical device manufactured by Smile Development Corp. It received FDA 510(k) clearance on 2018-01-19 under approval number K171674. 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 Angel Align System?

Angel Align System is a medical device that received FDA 510(k) clearance on 2018-01-19. It is manufactured by Smile Development Corp. The 510(k) number is K171674.

When was Angel Align System approved by the FDA?

Angel Align System received FDA 510(k) clearance on 2018-01-19, under approval number K171674.

What company makes Angel Align System?

Angel Align System is manufactured by Smile Development Corp.

What is the FDA product code for Angel Align System?

The FDA product code for Angel Align System is NXC.

Related Clinical Trials

NCT07586098 AI-assisted Diagnosis, Triage and Assessment of Hearing Loss and Tinnitus NOT_YET_RECRUITING NCT07264127 Clinical Performance of the I-arch System During the Initial Stage of Orthodontic Treatment RECRUITING NCT06594705 The JenaValve ALIGN-AR LVAD Registry RECRUITING

Related PubMed Literature

PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Related Devices (Code: NXC)

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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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