STR8 Clear Aligner
K-Number: K223141 · 2023-04-24
ApplicantStr8 Oral Care
Decision Date2023-04-24
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
STR8 Clear Aligner is a medical device manufactured by Str8 Oral Care. It received FDA 510(k) clearance on 2023-04-24 under approval number K223141. 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 STR8 Clear Aligner?
STR8 Clear Aligner is a medical device that received FDA 510(k) clearance on 2023-04-24. It is manufactured by Str8 Oral Care. The 510(k) number is K223141.
When was STR8 Clear Aligner approved by the FDA?
STR8 Clear Aligner received FDA 510(k) clearance on 2023-04-24, under approval number K223141.
What company makes STR8 Clear Aligner?
STR8 Clear Aligner is manufactured by Str8 Oral Care.
What is the FDA product code for STR8 Clear Aligner?
The FDA product code for STR8 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.