Red, White & Blue

FDA 510(k) K040874 · Allesee Orthodontic Appliances

Substantially Equivalent

510(k) numberK040874

Submission

Device name
Red, White & Blue
Applicant
Allesee Orthodontic Appliances
Orange, CA, US
Received
April 2, 2004
Decision date
June 18, 2004
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 Red, White & Blue cleared by the FDA?

Red, White & Blue (K040874) received a 510(k) decision of Substantially Equivalent on June 18, 2004, 77 days after the submission was received.

What is the product code of K040874?

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