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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 the device name listed in this FDA 510(k) record. The listed applicant is Smile Development Corp. It received FDA 510(k) clearance on 2018-01-19 under 510(k) 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. The listed applicant is Smile Development Corp. The 510(k) number is K171674.

When did Angel Align System receive FDA 510(k) clearance?

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

Who is the listed applicant for Angel Align System?

The FDA 510(k) record lists Smile Development Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Angel Align System?

The FDA product code for Angel Align System 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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