SunClear Aligner system
K-Number: K190394 · 2019-12-16
ApplicantSun Dental Laboratories, LLC
Decision Date2019-12-16
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SunClear Aligner system is a medical device manufactured by Sun Dental Laboratories, LLC. It received FDA 510(k) clearance on 2019-12-16 under approval number K190394. 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 SunClear Aligner system?
SunClear Aligner system is a medical device that received FDA 510(k) clearance on 2019-12-16. It is manufactured by Sun Dental Laboratories, LLC. The 510(k) number is K190394.
When was SunClear Aligner system approved by the FDA?
SunClear Aligner system received FDA 510(k) clearance on 2019-12-16, under approval number K190394.
What company makes SunClear Aligner system?
SunClear Aligner system is manufactured by Sun Dental Laboratories, LLC.
What is the FDA product code for SunClear Aligner system?
The FDA product code for SunClear Aligner system is NXC.
Related Clinical Trials
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.