FDA 510(k)

SmileSeries

K-Number: K221097 · 2022-07-14

ApplicantOrdont Orthodontic Laboratories, Inc.

Decision Date2022-07-14

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

SmileSeries is the device name listed in this FDA 510(k) record. The listed applicant is Ordont Orthodontic Laboratories, Inc.. It received FDA 510(k) clearance on 2022-07-14 under 510(k) number K221097. 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 SmileSeries?

SmileSeries is a medical device that received FDA 510(k) clearance on 2022-07-14. The listed applicant is Ordont Orthodontic Laboratories, Inc.. The 510(k) number is K221097.

When did SmileSeries receive FDA 510(k) clearance?

SmileSeries received FDA 510(k) clearance on 2022-07-14, under 510(k) number K221097.

Who is the listed applicant for SmileSeries?

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

What is the FDA product code for SmileSeries?

The FDA product code for SmileSeries 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) Limited K250739Primeprint Direct AlignerDreve Dentamid GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.