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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
DMETEC 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
ESSENTIAL DENTAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN COXO MEDICAL INSTRUMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUILIN REFINE MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MECTRON S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
MICRON CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NANNING VV DENTAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SATELEC-ACTEON GROUP
  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
W&H DENTALWERK BUERMOSS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 356 356
2018 289 289
2019 302 302
2020 164 164
2021 166 166
2022 165 165
2023 210 210
2024 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 875 875
Break 575 575
Restricted Flow rate 315 315
Temperature Problem 117 117
No Flow 70 70
Infusion or Flow Problem 19 19
Device Operates Differently Than Expected 13 13
Improper Flow or Infusion 12 12
Material Fragmentation 12 12
Detachment Of Device Component 12 12
Insufficient Information 9 9
Insufficient Flow or Under Infusion 8 8
Device Emits Odor 7 7
Fluid/Blood Leak 7 7
Fracture 7 7
Excessive Heating 7 7
Unintended Electrical Shock 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Component Missing 5 5
Smoking 5 5
Mechanical Problem 4 4
Leak/Splash 4 4
Detachment of Device or Device Component 4 4
Patient-Device Incompatibility 4 4
Noise, Audible 4 4
Power Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Defective Device 3 3
Melted 3 3
Complete Blockage 2 2
Decrease in Pressure 2 2
Difficult to Remove 2 2
Defective Component 2 2
Loose or Intermittent Connection 2 2
Inaccurate Flow Rate 2 2
Sparking 2 2
Vibration 2 2
Device Dislodged or Dislocated 2 2
Moisture or Humidity Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Integrity Problem 2 2
Ejection Problem 2 2
Appropriate Term/Code Not Available 2 2
Device Handling Problem 1 1
Activation Problem 1 1
Separation Problem 1 1
Material Twisted/Bent 1 1
Naturally Worn 1 1
Output Problem 1 1
Free or Unrestricted Flow 1 1
Blocked Connection 1 1
Device Maintenance Issue 1 1
Difficult to Insert 1 1
Intermittent Continuity 1 1
Corroded 1 1
Material Discolored 1 1
Electrical /Electronic Property Problem 1 1
Thermal Decomposition of Device 1 1
Alarm Not Visible 1 1
Bent 1 1
Obstruction of Flow 1 1
Material Separation 1 1
Device Stops Intermittently 1 1
Use of Device Problem 1 1
Product Quality Problem 1 1
Failure to Power Up 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 919 919
No Clinical Signs, Symptoms or Conditions 589 589
No Known Impact Or Consequence To Patient 225 225
Insufficient Information 90 90
No Information 80 80
Foreign Body In Patient 27 27
Burn(s) 24 24
Device Embedded In Tissue or Plaque 19 19
Burn, Thermal 11 11
Pain 7 7
No Code Available 6 6
Swelling 4 4
Injury 4 4
Numbness 3 3
Discomfort 3 3
Needle Stick/Puncture 3 3
Patient Problem/Medical Problem 3 3
Tinnitus 3 3
Hemorrhage/Bleeding 2 2
Unspecified Infection 2 2
No Patient Involvement 2 2
Superficial (First Degree) Burn 2 2
Fluid Discharge 1 1
Bowel Perforation 1 1
Electric Shock 1 1
Sensitivity of Teeth 1 1
Post Operative Wound Infection 1 1
Post Traumatic Wound Infection 1 1
Laceration(s) 1 1
Undesired Nerve Stimulation 1 1
Hypersensitivity/Allergic reaction 1 1
Dyspnea 1 1
Airway Obstruction 1 1
Exposure to Body Fluids 1 1
Tissue Damage 1 1
Burning Sensation 1 1
Dysphasia 1 1
Skin Discoloration 1 1
Sinus Perforation 1 1
Skin Burning Sensation 1 1
Unspecified Tissue Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Electro Medical Systems SA II Apr-24-2024
2 Sonendo Inc II Nov-14-2022
3 Sonendo Inc II May-28-2020
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