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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device handpiece, air-powered, dental
Regulation Description Dental handpiece and accessories.
Product CodeEFB
Regulation Number 872.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
BEIJING DONGBO DENTAL HANDPIECE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DENTALEZ, INC.
  SUBSTANTIALLY EQUIVALENT 2
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN CICADA DENTAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN WENJIAN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
J. MORITA USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KALTENBACH & VOIGT GMBH
  SUBSTANTIALLY EQUIVALENT 1
MICROP TECHNOLOGY (TAIWAN), INC.
  SUBSTANTIALLY EQUIVALENT 2
NAKANISHI, INC.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO HPDOVE DENTAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PREMIUM PLUS INTERNATIONAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TTBIO CORP.
  SUBSTANTIALLY EQUIVALENT 1
W & H DENTALWERK BUERMOOS GMBH
  SUBSTANTIALLY EQUIVALENT 1
W&H DENTALWERK BURMOOS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 153 153
2018 81 81
2019 117 399
2020 94 334
2021 123 670

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 265 790
Detachment of Device or Device Component 207 742
Detachment Of Device Component 39 39
Mechanical Problem 28 28
Use of Device Problem 11 11
Improper or Incorrect Procedure or Method 10 10
Device Slipped 10 10
Device Handling Problem 10 10
Device Maintenance Issue 8 8
Break 7 7
Maintenance Does Not Comply To Manufacturers Recommendations 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Physical Resistance/Sticking 6 6
Dent in Material 5 5
Unintended Ejection 5 5
Component Falling 5 5
Migration or Expulsion of Device 4 4
Misassembly by Users 4 4
Fitting Problem 4 8
Device Operates Differently Than Expected 4 4
Device Fell 4 4
Defective Device 3 8
Loose or Intermittent Connection 3 3
Material Separation 3 3
Failure To Service 2 2
Device Reprocessing Problem 2 2
Temperature Problem 2 2
Device Dislodged or Dislocated 2 2
Failure to Shut Off 1 1
Gas Leak 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Problem with Sterilization 1 1
Unintended Movement 1 1
Activation, Positioning or SeparationProblem 1 1
Insufficient Information 1 1
Material Fragmentation 1 1
Use of Incorrect Control Settings 1 1
Disassembly 1 1
Entrapment of Device 1 1
Fail-Safe Design Failure 1 1
Inadequate Service 1 1
Misassembled 1 1
Premature Separation 1 1
Failure to Clean Adequately 1 1
Misassembly During Maintenance/Repair 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 284 732
No Clinical Signs, Symptoms or Conditions 129 749
Burn(s) 66 474
Foreign Body In Patient 46 46
No Known Impact Or Consequence To Patient 28 28
Burn, Thermal 23 23
Patient Problem/Medical Problem 21 21
Injury 14 76
No Code Available 10 10
Tissue Damage 6 6
No Information 5 73
Insufficient Information 3 170
Swelling 3 3
Tooth Fracture 3 3
Choking 2 2
Laceration(s) 2 2
Pain 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Partial thickness (Second Degree) Burn 2 2
Cough 1 1
Scar Tissue 1 1
Pulmonary Emphysema 1 1
Hemorrhage/Bleeding 1 1
Abrasion 1 1
Air Embolism 1 1
Airway Obstruction 1 1
Chemical Exposure 1 1
Superficial (First Degree) Burn 1 1

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