FDA 510(k)

Krystal Klear Aligners

K-Number: K182388 · 2019-12-19

Decision Date2019-12-19

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Krystal Klear Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Shatkin F.I.R.S.T., LLC. It received FDA 510(k) clearance on 2019-12-19 under 510(k) number K182388. 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 Krystal Klear Aligners?

Krystal Klear Aligners is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Shatkin F.I.R.S.T., LLC. The 510(k) number is K182388.

When did Krystal Klear Aligners receive FDA 510(k) clearance?

Krystal Klear Aligners received FDA 510(k) clearance on 2019-12-19, under 510(k) number K182388.

Who is the listed applicant for Krystal Klear Aligners?

The FDA 510(k) record lists Shatkin F.I.R.S.T., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Krystal Klear Aligners?

The FDA product code for Krystal Klear Aligners 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.