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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implant, endosseous, orthodontic
Definition It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
Product CodeOAT
Regulation Number 872.3640
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO CETEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOMATERIALS KOREA, INC
  SUBSTANTIALLY EQUIVALENT 1
BLUE SKY BIO, LLC.
  SUBSTANTIALLY EQUIVALENT 1
BOMEI CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CRANIOFACIAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTOS INC
  SUBSTANTIALLY EQUIVALENT 1
GNI CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MICROWARE PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MK MEDITECH INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROIMTECH SAGLIK URUNLERI ANONIM SIRKETI
  SUBSTANTIALLY EQUIVALENT 1
SYNTEC SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TECHWIN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZE FANG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 38 26
2021 68 53
2022 84 84
2023 78 78
2024 24 25

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Osseointegrate 259 235
Loss of Osseointegration 13 11
Fracture 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Detachment of Device or Device Component 2 2
Difficult to Insert 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 131 118
Fibrosis 121 109
Pain 22 21
Unspecified Infection 17 15
Inflammation 16 16
Tissue Damage 16 15
Swelling/ Edema 10 8
Hemorrhage/Bleeding 10 9
Failure of Implant 6 0
Inadequate Osseointegration 3 0
Hypersensitivity/Allergic reaction 2 2
Insufficient Information 2 2
Increased Sensitivity 2 2
Fistula 1 1

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