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510(k) K201410

VENUS Bracket, ROSE Bracket by Gni Co., Ltd. — Product Code NJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2021
Date Received
May 28, 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 by Gni Co., Ltd.

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  • K182672 — ROSA Bracket (November 15, 2019)

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  • 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)
  • K201038 — Luce Ceramic Bracket (October 9, 2020)
  • K200148 — LightForce Orthodontic System (LFO System) (February 21, 2020)
  • K182672 — ROSA Bracket (November 15, 2019)