Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
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
GNI CO., LTD
  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
2020 38 26
2021 68 53
2022 84 84
2023 78 78
2024 35 44
2025 18 20

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Osseointegrate 285 271
Loss of Osseointegration 14 12
Adverse Event Without Identified Device or Use Problem 10 10
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 149 140
Fibrosis 132 124
Pain 24 23
Unspecified Infection 19 17
Inflammation 18 18
Tissue Damage 16 15
Swelling/ Edema 11 9
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
Implant Pain 1 1
Fistula 1 1

-
-