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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bracket, ceramic, orthodontic
Definition 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.
Product CodeNJM
Regulation Number 872.5470
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 1
BIO CETEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOCETEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DYNA FLEX
  SUBSTANTIALLY EQUIVALENT 1
GNI CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
LIGHTFORCE ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 3
LUCE CASTLE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEM DENTAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSUN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RAYENCE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 1
WORLD CLASS TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or Separation Problem 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Abrasion 1 1
Patient Problem/Medical Problem 1 1

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