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510(k) K200148

LightForce Orthodontic System (LFO System) by Lightforce Orthodontics — Product Code NJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2020
Date Received
January 22, 2020
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

  • K232827 — LightForce Orthodontic System (September 14, 2023)
  • K222764 — LightForce Orthodontic System (September 14, 2022)

Other clearances for product code NJM

  • K232827 — LightForce Orthodontic System (September 14, 2023)
  • 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)
  • K182672 — ROSA Bracket (November 15, 2019)