Sureclear aligners
K-Number: K171860 · 2018-01-05
ApplicantEmergo Global Consulting, LLC
Decision Date2018-01-05
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Sureclear aligners is a medical device manufactured by Emergo Global Consulting, LLC. It received FDA 510(k) clearance on 2018-01-05 under approval number K171860. 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 Sureclear aligners?
Sureclear aligners is a medical device that received FDA 510(k) clearance on 2018-01-05. It is manufactured by Emergo Global Consulting, LLC. The 510(k) number is K171860.
When was Sureclear aligners approved by the FDA?
Sureclear aligners received FDA 510(k) clearance on 2018-01-05, under approval number K171860.
What company makes Sureclear aligners?
Sureclear aligners is manufactured by Emergo Global Consulting, LLC.
What is the FDA product code for Sureclear aligners?
The FDA product code for Sureclear 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.