6MS Invisible Aligner
K-Number: K210652 · 2021-06-02
ApplicantSms Opco, LLC
Decision Date2021-06-02
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
6MS Invisible Aligner is a medical device manufactured by Sms Opco, LLC. It received FDA 510(k) clearance on 2021-06-02 under approval number K210652. 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 6MS Invisible Aligner?
6MS Invisible Aligner is a medical device that received FDA 510(k) clearance on 2021-06-02. It is manufactured by Sms Opco, LLC. The 510(k) number is K210652.
When was 6MS Invisible Aligner approved by the FDA?
6MS Invisible Aligner received FDA 510(k) clearance on 2021-06-02, under approval number K210652.
What company makes 6MS Invisible Aligner?
6MS Invisible Aligner is manufactured by Sms Opco, LLC.
What is the FDA product code for 6MS Invisible Aligner?
The FDA product code for 6MS Invisible Aligner is NXC.
Related Devices (Code: NXC)
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.