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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
3M HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 1
BIO CETEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOCETEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GNI CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
KOROAD AMERICA
  SUBSTANTIALLY EQUIVALENT 1
LIGHTFORCE ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 2
LUCE CASTLE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEM DENTAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ORMCO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ORTHO ORGANIZERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSUN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RAYENCE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 2
WORLD CLASS TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Activation, Positioning or Separation Problem 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tooth Fracture 3 3
Patient Problem/Medical Problem 1 1
Therapeutic Effects, Unexpected 1 1

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