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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, operative dental
Regulation Description Dental operative unit and accessories.
Product CodeEIA
Regulation Number 872.6640
Device Class 1


Premarket Reviews
ManufacturerDecision
A-DEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
BDC DENTAL CORPORATION , LTD.
  SUBSTANTIALLY EQUIVALENT 1
DCI INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
FIRSTAR DENTAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN SAFETY MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG YADENG MEDICAL APPARATUS CO., LTD.,
  SUBSTANTIALLY EQUIVALENT 1
LARES RESEARCH
  SUBSTANTIALLY EQUIVALENT 1
MEGAGEN IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MGNEWTON , LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIDMARK CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MIPONT MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLSEN INDUSTRIA E COMERCIO S.A.
  SUBSTANTIALLY EQUIVALENT 1
OLSEN INDÚSTRIA E COMÉRCIO S.A.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K213742  Infinity Pro, Logic, Quality, Sprint
OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT COMPANY., LTD. CHAIR BUSINESS
  SUBSTANTIALLY EQUIVALENT 1
SHINHUNG COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 48 131
2021 49 122
2022 44 131
2023 53 137
2024 53 169
2025 47 160

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 106 465
Detachment of Device or Device Component 60 146
Fracture 36 113
Unintended Power Up 24 29
Device Remains Activated 20 24
Fluid/Blood Leak 16 32
Material Disintegration 10 16
Unintended Ejection 6 9
Material Fragmentation 5 5
Defective Device 3 3
Break 2 2
Smoking 2 2
Patient-Device Incompatibility 1 1
Insufficient Information 1 1
Vibration 1 1
Contamination /Decontamination Problem 1 1
Patient Device Interaction Problem 1 1
Ejection Problem 1 1
Fail-Safe Problem 1 1
Failure to Power Up 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Product Quality Problem 1 1
Corroded 1 6
Improper or Incorrect Procedure or Method 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 261 809
Burn(s) 40 276
No Patient Involvement 31 81
Insufficient Information 21 135
No Known Impact Or Consequence To Patient 4 19
No Consequences Or Impact To Patient 3 28
Hypersensitivity/Allergic reaction 2 2
No Information 2 8
Unspecified Infection 1 1
Superficial (First Degree) Burn 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body In Patient 1 1
Pain 1 1
Swelling/ Edema 1 1
Skin Tears 1 1
Full thickness (Third Degree) Burn 1 1

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