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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
Regulation Description Dental handpiece and accessories.
Product CodeEGS
Regulation Number 872.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
DIRECTA AB
  SUBSTANTIALLY EQUIVALENT 1
NAKANISHI INC.
  SUBSTANTIALLY EQUIVALENT 1
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2015 166 166
2016 299 299
2017 316 316
2018 230 230
2019 219 219
2020 134 134

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 987 987
Temperature Problem 195 195
Detachment of Device or Device Component 190 190
Detachment Of Device Component 106 106
Handpiece 102 102
Mechanical Problem 57 57
Dent in Material 51 51
Cap 37 37
Loose or Intermittent Connection 25 25
Insufficient Information 24 24
Failure To Service 22 22
Device Operates Differently Than Expected 19 19
Therapeutic or Diagnostic Output Failure 18 18
Physical Resistance/Sticking 18 18
Component Falling 14 14
Defective Device 14 14
Physical Property Issue 13 13
Device Handling Problem 13 13
Computer Operating System Problem 10 10
Break 9 9
Device Maintenance Issue 9 9
Improper or Incorrect Procedure or Method 9 9
Noise, Audible 8 8
Retraction Problem 6 6
Use of Device Problem 6 6
Appropriate Term/Code Not Available 5 5
Device Dislodged or Dislocated 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Malposition of Device 3 3
Device Damaged by Another Device 3 3
Material Separation 3 3
Incorrect Measurement 3 3
Loss of Power 2 2
Disassembly 2 2
Component Missing 2 2
Smoking 2 2
Fitting Problem 2 2
Defective Component 2 2
Unexpected Therapeutic Results 2 2
Material Deformation 2 2
Data Problem 2 2
Device Fell 1 1
Unintended Movement 1 1
Device Subassembly 1 1
Switch, Push Button 1 1
Device Inoperable 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Displays Incorrect Message 1 1
Output above Specifications 1 1
Sticking 1 1
Device Stops Intermittently 1 1
Computer Software Problem 1 1
Corroded 1 1
Disconnection 1 1
Entrapment of Device 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Output Problem 1 1
Device Issue 1 1
Failure to Align 1 1
Device Slipped 1 1
Fluid Leak 1 1
Fracture 1 1
Labelling, Instructions for Use or Training Problem 1 1
Device Reprocessing Problem 1 1
Crack 1 1
Failure to Cycle 1 1
Screw 1 1
Bearings 1 1
Cup 1 1
Heads 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 728 728
Burn(s) 310 310
Burn, Thermal 234 234
Injury 179 179
Patient Problem/Medical Problem 160 160
No Known Impact Or Consequence To Patient 160 160
No Clinical Signs, Symptoms or Conditions 51 51
Partial thickness (Second Degree) Burn 33 33
Foreign Body In Patient 21 21
No Information 20 20
No Patient Involvement 11 11
Pain 9 9
No Code Available 8 8
Swelling 6 6
Burning Sensation 5 5
Full thickness (Third Degree) Burn 4 4
Insufficient Information 4 4
Laceration(s) 3 3
Complaint, Ill-Defined 2 2
Tissue Damage 2 2
Numbness 2 2
Superficial (First Degree) Burn 2 2
Erosion 2 2
Ulceration 1 1
Perforation 1 1
Hemorrhage/Bleeding 1 1
Scar Tissue 1 1
Scarring 1 1
Device Embedded In Tissue or Plaque 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bien Air Dental SA II Sep-21-2015
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