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510(k) K232827

LightForce Orthodontic System by Lightforce Orthodontics — Product Code NJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2023
Date Received
September 13, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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 clearances by Lightforce Orthodontics

  • K222764 — LightForce Orthodontic System (September 14, 2022)
  • K200148 — LightForce Orthodontic System (LFO System) (February 21, 2020)

Other clearances for product code NJM

  • K232011 — Cleo (July 7, 2023)
  • K231635 — A-Line Advanced (June 6, 2023)
  • K230225 — DynaFlex Clear Brackets & Buttons (June 5, 2023)
  • K222847 — Ceramic Brackets Orthometric (May 4, 2023)
  • K222764 — LightForce Orthodontic System (September 14, 2022)
  • K220689 — Vatech Clismile (May 6, 2022)
  • K201410 — VENUS Bracket, ROSE Bracket (March 12, 2021)
  • K201038 — Luce Ceramic Bracket (October 9, 2020)
  • K200148 — LightForce Orthodontic System (LFO System) (February 21, 2020)
  • K182672 — ROSA Bracket (November 15, 2019)