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FDA 510(k)

Pearl Clear Aligner

K-Number: K242715 · 2025-01-16

ApplicantPearl Digital, Inc.
Decision Date2025-01-16
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Pearl Clear Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Pearl Digital, Inc.. It received FDA 510(k) clearance on 2025-01-16 under 510(k) number K242715. 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 Pearl Clear Aligner?

Pearl Clear Aligner is a medical device that received FDA 510(k) clearance on 2025-01-16. The listed applicant is Pearl Digital, Inc.. The 510(k) number is K242715.

When did Pearl Clear Aligner receive FDA 510(k) clearance?

Pearl Clear Aligner received FDA 510(k) clearance on 2025-01-16, under 510(k) number K242715.

Who is the listed applicant for Pearl Clear Aligner?

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

What is the FDA product code for Pearl Clear Aligner?

The FDA product code for Pearl Clear Aligner 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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