TRIOCLEAR System
K-Number: K193622 · 2021-07-06
Decision Date2021-07-06
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TRIOCLEAR System is a medical device manufactured by Perfection Aligner System Hong Kong Limited. It received FDA 510(k) clearance on 2021-07-06 under approval number K193622. 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 TRIOCLEAR System?
TRIOCLEAR System is a medical device that received FDA 510(k) clearance on 2021-07-06. It is manufactured by Perfection Aligner System Hong Kong Limited. The 510(k) number is K193622.
When was TRIOCLEAR System approved by the FDA?
TRIOCLEAR System received FDA 510(k) clearance on 2021-07-06, under approval number K193622.
What company makes TRIOCLEAR System?
TRIOCLEAR System is manufactured by Perfection Aligner System Hong Kong Limited.
What is the FDA product code for TRIOCLEAR System?
The FDA product code for TRIOCLEAR System 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.