Aerodentis System
K-Number: K192069 · 2020-05-06
ApplicantDror Orthodesign
Decision Date2020-05-06
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Aerodentis System is a medical device manufactured by Dror Orthodesign. It received FDA 510(k) clearance on 2020-05-06 under approval number K192069. 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 Aerodentis System?
Aerodentis System is a medical device that received FDA 510(k) clearance on 2020-05-06. It is manufactured by Dror Orthodesign. The 510(k) number is K192069.
When was Aerodentis System approved by the FDA?
Aerodentis System received FDA 510(k) clearance on 2020-05-06, under approval number K192069.
What company makes Aerodentis System?
Aerodentis System is manufactured by Dror Orthodesign.
What is the FDA product code for Aerodentis System?
The FDA product code for Aerodentis 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.