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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 INDÚSTRIA E COMÉRCIO S.A.
  SUBSTANTIALLY EQUIVALENT 1
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
2021 49 122
2022 44 131
2023 53 137
2024 53 169
2025 47 158
2026 17 61

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 96 436
Detachment of Device or Device Component 54 131
Fracture 33 99
Device Remains Activated 18 20
Unintended Power Up 18 23
Fluid/Blood Leak 12 28
Material Disintegration 11 17
Unintended Ejection 6 9
Material Fragmentation 5 5
Defective Device 3 3
Smoking 2 2
Break 1 1
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
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 248 763
Burn(s) 40 302
Insufficient Information 19 122
Hypersensitivity/Allergic reaction 2 2
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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