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510(k) K163117

Alpha Pure by Koroad America — Product Code NJM

K163117 is an FDA 510(k) premarket notification submitted by Koroad America for the device "Alpha Pure". The FDA issued a decision of Substantially Equivalent on May 9, 2017. The device falls under product code NJM (Bracket, Ceramic, Orthodontic), a Class II device regulated under 21 CFR 872.5470.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2017
Date Received
Nov 7, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Ceramic, Orthodontic
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type
510(k)

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.

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  • K230225 — DynaFlex Clear Brackets & Buttons (Jun 5, 2023)
  • K222847 — Ceramic Brackets Orthometric (May 4, 2023)
  • K222764 — LightForce Orthodontic System (Sep 14, 2022)
  • K220689 — Vatech Clismile (May 6, 2022)
  • K201410 — VENUS Bracket, ROSE Bracket (Mar 12, 2021)
  • K201038 — Luce Ceramic Bracket (Oct 9, 2020)
  • K200148 — LightForce Orthodontic System (LFO System) (Feb 21, 2020)

FDA data resources