Clearform Aligners
K-Number: K191838 · 2020-03-20
ApplicantMotor City Lab Works
Decision Date2020-03-20
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Clearform Aligners is a medical device manufactured by Motor City Lab Works. It received FDA 510(k) clearance on 2020-03-20 under approval number K191838. 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 Clearform Aligners?
Clearform Aligners is a medical device that received FDA 510(k) clearance on 2020-03-20. It is manufactured by Motor City Lab Works. The 510(k) number is K191838.
When was Clearform Aligners approved by the FDA?
Clearform Aligners received FDA 510(k) clearance on 2020-03-20, under approval number K191838.
What company makes Clearform Aligners?
Clearform Aligners is manufactured by Motor City Lab Works.
What is the FDA product code for Clearform Aligners?
The FDA product code for Clearform Aligners 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.