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510(k) K201038

Luce Ceramic Bracket by Luce Castle Co., Ltd. — Product Code NJM

K201038 is an FDA 510(k) premarket notification submitted by Luce Castle Co., Ltd. for the device "Luce Ceramic Bracket". The FDA issued a decision of Substantially Equivalent on October 9, 2020. 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
October 9, 2020
Date Received
April 20, 2020
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

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 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)
  • K200148 — LightForce Orthodontic System (LFO System) (February 21, 2020)
  • K182672 — ROSA Bracket (November 15, 2019)

FDA data resources