FS Aligner

FDA 510(k) K093821 · Allesee Orthodontic Appliances

Substantially Equivalent

510(k) numberK093821

Submission

Device name
FS Aligner
Applicant
Allesee Orthodontic Appliances
Orange, CA, US
Received
December 14, 2009
Decision date
August 27, 2010
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 FS Aligner cleared by the FDA?

FS Aligner (K093821) received a 510(k) decision of Substantially Equivalent on August 27, 2010, 256 days after the submission was received.

What is the product code of K093821?

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