Orthodontic Appliance

FDA 510(k) K181747 · Shandong Huge Dental Material Corporation

Substantially Equivalent

510(k) numberK181747

Submission

Device name
Orthodontic Appliance
Applicant
Shandong Huge Dental Material Corporation
Rizhao City, CN
Received
July 2, 2018
Decision date
April 18, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NXC – Aligner, Sequential
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5470
Specialty
Dental

The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.

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Questions and answers

When was Orthodontic Appliance cleared by the FDA?

Orthodontic Appliance (K181747) received a 510(k) decision of Substantially Equivalent on April 18, 2019, 290 days after the submission was received.

What is the product code of K181747?

The FDA product code is NXC – Aligner, Sequential, a Class II (moderate risk) device regulated under 21 CFR 872.5470.