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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
Regulation Description Endosseous dental implant.
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
BIOMATERIALS KOREA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOMEI CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CRANIOFACIAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
LEONE S.P.A.
  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
2021 68 53
2022 84 84
2023 78 78
2024 35 44
2025 35 39
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Osseointegrate 266 265
Adverse Event Without Identified Device or Use Problem 12 12
Loss of Osseointegration 12 11
Fracture 9 9
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 148 147
Fibrosis 131 128
Pain 22 21
Unspecified Infection 18 17
Inflammation 17 17
Swelling/ Edema 9 9
Hemorrhage/Bleeding 8 8
Increased Sensitivity 3 3
Hypersensitivity/Allergic reaction 2 2
Insufficient Information 2 2
Implant Pain 1 1
Fistula 1 1

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