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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device handpiece, contra- and right-angle attachment, dental
Product CodeEGS
Regulation Number 872.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
AJK ENGINEERING, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANGSTROM MFG., INC.
  SUBSTANTIALLY EQUIVALENT 2
ANTHOGYR SAS
  SUBSTANTIALLY EQUIVALENT 1
BONART CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTALEZ, INC
  SUBSTANTIALLY EQUIVALENT 1
DIRECTA AB
  SUBSTANTIALLY EQUIVALENT 1
ESSENTIAL DENTAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HANDPIECE HEADQUARTERS
  SUBSTANTIALLY EQUIVALENT 2
J. MORITA USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KAVO DENTAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
LARES RESEARCH
  SUBSTANTIALLY EQUIVALENT 1
MICRO-NX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NAKANISHI INC.
  SUBSTANTIALLY EQUIVALENT 4
NAKANISHI, INC.
  SUBSTANTIALLY EQUIVALENT 1
PREMIUM PLUS INTERNATIONAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
SCICAN GMBH
  SUBSTANTIALLY EQUIVALENT 1
SIRONA DENTAL SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1
THUNDER TIGER CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 38 38
2015 166 166
2016 299 299
2017 316 316
2018 230 230
2019 219 219
2020 191 191
2021 294 294
2022 279 279
2023 115 118
2024 54 54

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 1288 1288
Detachment of Device or Device Component 591 592
Temperature Problem 212 212
Mechanical Problem 154 154
Detachment Of Device Component 107 107
Dent in Material 78 78
Insufficient Information 48 50
Output Problem 45 45
Therapeutic or Diagnostic Output Failure 43 43
Physical Resistance/Sticking 38 38
Defective Device 35 35
Loose or Intermittent Connection 30 30
Device Handling Problem 24 24
Failure To Service 22 22
Break 20 20
Device Operates Differently Than Expected 20 20
Improper or Incorrect Procedure or Method 15 15
Component Falling 14 14
Noise, Audible 13 13
Physical Property Issue 13 13
Use of Device Problem 13 13
Failure to Align 11 11
Computer Operating System Problem 10 10
Device Maintenance Issue 10 10
Mechanics Altered 9 9
Incorrect Measurement 8 8
Device Slipped 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Retraction Problem 6 6
Material Separation 6 6
Data Problem 5 5
Appropriate Term/Code Not Available 5 5
Device Dislodged or Dislocated 4 4
Fitting Problem 3 3
Defective Component 3 3
Component Missing 3 3
Mechanical Jam 3 3
Entrapment of Device 3 3
Device Damaged by Another Device 3 3
Device Fell 3 3
Calibration Problem 3 3
Unintended Movement 3 3
Material Deformation 3 3
Malposition of Device 3 3
Maintenance Does Not Comply To Manufacturers Recommendations 3 3
Unintended Collision 2 2
Unexpected Shutdown 2 2
Loss of Power 2 2
Corroded 2 2
Unexpected Therapeutic Results 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 733 733
Burn(s) 531 531
No Clinical Signs, Symptoms or Conditions 523 526
Burn, Thermal 246 246
Injury 179 179
Patient Problem/Medical Problem 160 160
No Known Impact Or Consequence To Patient 160 160
Partial thickness (Second Degree) Burn 111 111
Insufficient Information 82 82
Superficial (First Degree) Burn 46 46
Foreign Body In Patient 33 33
No Information 20 20
Pain 17 17
No Patient Involvement 11 11
No Code Available 8 8
Burning Sensation 7 7
Laceration(s) 7 7
Swelling 6 6
Full thickness (Third Degree) Burn 5 5
Tooth Fracture 4 4
Device Embedded In Tissue or Plaque 4 4
Tissue Damage 3 3
Complaint, Ill-Defined 2 2
Blister 2 2
Needle Stick/Puncture 2 2
Numbness 2 2
Scar Tissue 2 2
Skin Tears 2 2
Erosion 2 2
Skin Burning Sensation 2 2
Electric Shock 1 1
Perforation 1 1
Scarring 1 1
Peeling 1 1
Eye Injury 1 1
Ulceration 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bien Air Dental SA II Sep-21-2015
2 Young Dental Manufacturing I, LLC II Nov-09-2023
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