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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device scaler, ultrasonic
Product CodeELC
Regulation Number 872.4850
Device Class 2


Premarket Reviews
ManufacturerDecision
CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
E.M.S ELECTRO MEDICAL SYSTEMS S.A
  SUBSTANTIALLY EQUIVALENT 1
E.M.S ELECTRO MEDICAL SYSTEMS S.A.
  SUBSTANTIALLY EQUIVALENT 1
ENGINEERED ENDODONTICS
  SUBSTANTIALLY EQUIVALENT 1
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SCHLUMBOHM GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
SONENDO, INC
  SUBSTANTIALLY EQUIVALENT 1
SONENDO, INC.
  SUBSTANTIALLY EQUIVALENT 1
TTBIO CORP.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 289 289
2019 302 302
2020 164 164
2021 166 166
2022 165 165
2023 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 501 501
Break 413 413
Restricted Flow rate 275 275
Temperature Problem 69 69
No Flow 30 30
Infusion or Flow Problem 19 19
Improper Flow or Infusion 11 11
Material Fragmentation 10 10
Device Operates Differently Than Expected 8 8
Device Emits Odor 7 7
Insufficient Information 7 7
Fluid/Blood Leak 7 7
Insufficient Flow or Under Infusion 7 7
Unintended Electrical Shock 6 6
Component Missing 5 5
Excessive Heating 4 4
Noise, Audible 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Power Problem 3 3
Detachment of Device or Device Component 3 3
Patient-Device Incompatibility 3 3
Therapeutic or Diagnostic Output Failure 3 3
Defective Device 3 3
Mechanical Problem 3 3
Fracture 3 3
Detachment Of Device Component 3 3
Inaccurate Flow Rate 2 2
Leak/Splash 2 2
Loose or Intermittent Connection 2 2
Melted 2 2
Decrease in Pressure 2 2
Difficult to Remove 2 2
Sparking 2 2
Defective Component 2 2
Smoking 2 2
Appropriate Term/Code Not Available 2 2
Ejection Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Integrity Problem 2 2
Moisture or Humidity Problem 2 2
Naturally Worn 1 1
Device Dislodged or Dislocated 1 1
Free or Unrestricted Flow 1 1
Output Problem 1 1
Material Twisted/Bent 1 1
Blocked Connection 1 1
Device Handling Problem 1 1
Activation Problem 1 1
Separation Problem 1 1
Device Stops Intermittently 1 1
Vibration 1 1
Obstruction of Flow 1 1
Material Separation 1 1
Product Quality Problem 1 1
Failure to Power Up 1 1
Device Maintenance Issue 1 1
Difficult to Insert 1 1
Intermittent Continuity 1 1
Corroded 1 1
Electrical /Electronic Property Problem 1 1
Thermal Decomposition of Device 1 1
Complete Blockage 1 1
Alarm Not Visible 1 1
Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 615 615
No Clinical Signs, Symptoms or Conditions 390 390
No Known Impact Or Consequence To Patient 128 128
Insufficient Information 62 62
No Information 48 48
Foreign Body In Patient 16 16
Device Embedded In Tissue or Plaque 13 13
Burn(s) 8 8
Pain 6 6
Injury 4 4
Swelling 4 4
Burn, Thermal 4 4
Needle Stick/Puncture 3 3
Numbness 3 3
Tinnitus 2 2
Hemorrhage/Bleeding 2 2
No Code Available 2 2
No Patient Involvement 2 2
Patient Problem/Medical Problem 2 2
Bowel Perforation 1 1
Fluid Discharge 1 1
Electric Shock 1 1
Skin Burning Sensation 1 1
Unspecified Tissue Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Laceration(s) 1 1
Undesired Nerve Stimulation 1 1
Skin Discoloration 1 1
Dyspnea 1 1
Airway Obstruction 1 1
Exposure to Body Fluids 1 1
Tissue Damage 1 1
Dysphasia 1 1
Sensitivity of Teeth 1 1
Sinus Perforation 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sonendo Inc II Nov-14-2022
2 Sonendo Inc II May-28-2020
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