Alpha Pure

FDA 510(k) K163117 · Koroad America

Substantially Equivalent

510(k) numberK163117

Submission

Device name
Alpha Pure
Applicant
Koroad America
Newport Beach, CA, US
Received
November 7, 2016
Decision date
May 9, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NJM – Bracket, Ceramic, Orthodontic
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5470
Specialty
Dental

An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position.

Other 510(k)s with product code NJM

510(k)DeviceApplicantDecision
K232827LightForce Orthodontic SystemNJM · Traditional Lightforce Orthodontics09/14/2023SE
K232011CleoNJM · Traditional American Orthodontics07/07/2023SE
K231635A-Line AdvancedNJM · Traditional Biocetec Co., Ltd.06/06/2023SE
K230225DynaFlex Clear Brackets & ButtonsNJM · Traditional Dyna Flex06/05/2023SE
K222847Ceramic Brackets OrthometricNJM · Traditional Orthometric - Industria E Comercio DE Produtos…05/04/2023SE
K222764LightForce Orthodontic SystemNJM · Special Lightforce Orthodontics09/14/2022SE
K220689Vatech ClismileNJM · Traditional Rayence Co., Ltd.05/06/2022SE
K201410VENUS Bracket, ROSE BracketNJM · Traditional Gni Co., Ltd.03/12/2021SE
K201038Luce Ceramic BracketNJM · Traditional Luce Castle Co., Ltd.10/09/2020SE
K200148LightForce Orthodontic System (LFO System)NJM · Traditional Lightforce Orthodontics02/21/2020SE

Questions and answers

When was Alpha Pure cleared by the FDA?

Alpha Pure (K163117) received a 510(k) decision of Substantially Equivalent on May 9, 2017, 183 days after the submission was received.

What is the product code of K163117?

The FDA product code is NJM – Bracket, Ceramic, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.5470.