Krystal Klear Aligners
K-Number: K182388 · 2019-12-19
ApplicantShatkin F.I.R.S.T., LLC
Decision Date2019-12-19
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Krystal Klear Aligners is a medical device manufactured by Shatkin F.I.R.S.T., LLC. It received FDA 510(k) clearance on 2019-12-19 under approval number K182388. 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 Krystal Klear Aligners?
Krystal Klear Aligners is a medical device that received FDA 510(k) clearance on 2019-12-19. It is manufactured by Shatkin F.I.R.S.T., LLC. The 510(k) number is K182388.
When was Krystal Klear Aligners approved by the FDA?
Krystal Klear Aligners received FDA 510(k) clearance on 2019-12-19, under approval number K182388.
What company makes Krystal Klear Aligners?
Krystal Klear Aligners is manufactured by Shatkin F.I.R.S.T., LLC.
What is the FDA product code for Krystal Klear Aligners?
The FDA product code for Krystal Klear 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.