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 a medical device manufactured by Pearl Digital, Inc.. It received FDA 510(k) clearance on 2025-01-16 under approval 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. It is manufactured by Pearl Digital, Inc.. The 510(k) number is K242715.
When was Pearl Clear Aligner approved by the FDA?
Pearl Clear Aligner received FDA 510(k) clearance on 2025-01-16, under approval number K242715.
What company makes Pearl Clear Aligner?
Pearl Clear Aligner is manufactured by Pearl Digital, Inc..
What is the FDA product code for Pearl Clear Aligner?
The FDA product code for Pearl Clear Aligner is 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.