Orthodontic Appliance
K-Number: K181747 · 2019-04-18
Decision Date2019-04-18
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Orthodontic Appliance is a medical device manufactured by Shandong Huge Dental Material Corporation. It received FDA 510(k) clearance on 2019-04-18 under approval number K181747. 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 Orthodontic Appliance?
Orthodontic Appliance is a medical device that received FDA 510(k) clearance on 2019-04-18. It is manufactured by Shandong Huge Dental Material Corporation. The 510(k) number is K181747.
When was Orthodontic Appliance approved by the FDA?
Orthodontic Appliance received FDA 510(k) clearance on 2019-04-18, under approval number K181747.
What company makes Orthodontic Appliance?
Orthodontic Appliance is manufactured by Shandong Huge Dental Material Corporation.
What is the FDA product code for Orthodontic Appliance?
The FDA product code for Orthodontic Appliance is NXC.
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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.