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510(k) K182193

S-Line by Biocetec Co., Ltd. — Product Code NJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2019
Date Received
August 14, 2018
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 Biocetec Co., Ltd.

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  • K163467 — C-Line Orthodontic Ceramic Bracket (June 14, 2017)

Other clearances for product code NJM

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  • 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)