Clear Aligner
K-Number: K192767 · 2020-01-08
ApplicantRoyal Dental Lab
Decision Date2020-01-08
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Clear Aligner is a medical device manufactured by Royal Dental Lab. It received FDA 510(k) clearance on 2020-01-08 under approval number K192767. 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 Clear Aligner?
Clear Aligner is a medical device that received FDA 510(k) clearance on 2020-01-08. It is manufactured by Royal Dental Lab. The 510(k) number is K192767.
When was Clear Aligner approved by the FDA?
Clear Aligner received FDA 510(k) clearance on 2020-01-08, under approval number K192767.
What company makes Clear Aligner?
Clear Aligner is manufactured by Royal Dental Lab.
What is the FDA product code for Clear Aligner?
The FDA product code for 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.