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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
A-DEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN EAGLE INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASEPTICO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
COLTENE/WHALEDENT
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY INTERNTIONAL
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
DISCUS DENTAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
DMETEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DPM USA CORP.
  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
E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
  SUBSTANTIALLY EQUIVALENT 3
EMS ELECTRO MEDICAL SYSTEMS SA
  SUBSTANTIALLY EQUIVALENT 3
ENGINEERED ENDODONTICS
  SUBSTANTIALLY EQUIVALENT 1
ENGLER ENGINEERING CORP.
  SUBSTANTIALLY EQUIVALENT 1
ESSENTIAL DENTAL SYSTEMS INC.
  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
HU-FRIEDY MFG. CO., INC
  SUBSTANTIALLY EQUIVALENT 1
LAKONG MEDICAL DEVICE COMPANY, LTD
  SUBSTANTIALLY EQUIVALENT 1
MECTRON S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
MECTRON SPA
  SUBSTANTIALLY EQUIVALENT 2
MICRO-MEGA SOCIETE ANONYME
  SUBSTANTIALLY EQUIVALENT 1
MICRON CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
NAKANISHI, INC.
  SUBSTANTIALLY EQUIVALENT 2
NANNING BAOLAI MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NANNING VV DENTAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SATELEC-ACTEON GROUP
  SUBSTANTIALLY EQUIVALENT 6
SCHLUMBOHM GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
SONENDO, INC
  SUBSTANTIALLY EQUIVALENT 1
SONENDO, INC.
  SUBSTANTIALLY EQUIVALENT 6
TTBIO CORP.
  SUBSTANTIALLY EQUIVALENT 2
W&H DENTALWERK BUERMOSS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 37 37
2015 135 135
2016 169 169
2017 356 356
2018 289 289
2019 302 302
2020 164 164
2021 166 166
2022 165 165
2023 210 210
2024 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 1118 1118
Break 651 651
Restricted Flow rate 318 318
Temperature Problem 143 143
No Flow 75 75
Device Operates Differently Than Expected 20 20
Infusion or Flow Problem 19 19
Material Fragmentation 17 17
Fracture 15 15
Detachment Of Device Component 12 12
Improper Flow or Infusion 12 12
Insufficient Information 11 11
Insufficient Flow or Under Infusion 9 9
Excessive Heating 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Fluid/Blood Leak 7 7
Device Emits Odor 7 7
Volume Accuracy Problem 6 6
Unintended Electrical Shock 6 6
Material Integrity Problem 6 6
Detachment of Device or Device Component 5 5
Component Missing 5 5
Patient-Device Incompatibility 5 5
Noise, Audible 5 5
Smoking 5 5
Material Separation 5 5
Melted 5 5
Mechanical Problem 4 4
Leak/Splash 4 4
Inappropriate/Inadequate Shock/Stimulation 3 3
Power Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Defective Device 3 3
Defective Component 2 2
Sparking 2 2
Device Dislodged or Dislocated 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Moisture or Humidity Problem 2 2
Ejection Problem 2 2
Appropriate Term/Code Not Available 2 2
Difficult to Remove 2 2
Vibration 2 2
Loose or Intermittent Connection 2 2
Decrease in Pressure 2 2
Inaccurate Flow Rate 2 2
Complete Blockage 2 2
Electrical /Electronic Property Problem 2 2
Hole In Material 1 1
Difficult to Insert 1 1
Contamination 1 1
Intermittent Continuity 1 1
Corroded 1 1
Material Discolored 1 1
Thermal Decomposition of Device 1 1
Alarm Not Visible 1 1
Bent 1 1
Product Quality Problem 1 1
Peeled/Delaminated 1 1
Failure to Power Up 1 1
Device Maintenance Issue 1 1
Device Stops Intermittently 1 1
Use of Device Problem 1 1
Device Handling Problem 1 1
Activation Problem 1 1
Separation Problem 1 1
Naturally Worn 1 1
Output Problem 1 1
Material Twisted/Bent 1 1
Free or Unrestricted Flow 1 1
Obstruction of Flow 1 1
Device Or Device Fragments Location Unknown 1 1
Blocked Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1178 1178
No Clinical Signs, Symptoms or Conditions 606 606
No Known Impact Or Consequence To Patient 286 286
No Information 106 106
Insufficient Information 91 91
Burn(s) 35 35
Device Embedded In Tissue or Plaque 31 31
Foreign Body In Patient 31 31
Burn, Thermal 14 14
Pain 8 8
No Code Available 7 7
Swelling 6 6
Tinnitus 6 6
Injury 5 5
Patient Problem/Medical Problem 5 5
Discomfort 4 4
Needle Stick/Puncture 3 3
Numbness 3 3
Unspecified Infection 3 3
Hemorrhage/Bleeding 3 3
No Patient Involvement 3 3
Superficial (First Degree) Burn 2 2
Electric Shock 2 2
Hypersensitivity/Allergic reaction 2 2
Laceration(s) 2 2
Shock 2 2
Tissue Damage 2 2
Vertigo 2 2
Burning Sensation 1 1
Dizziness 1 1
Dysphasia 1 1
Disability 1 1
Sinus Perforation 1 1
Sensitivity of Teeth 1 1
Post Operative Wound Infection 1 1
Post Traumatic Wound Infection 1 1
Confusion/ Disorientation 1 1
Skin Discoloration 1 1
Peeling 1 1
Scarring 1 1
Undesired Nerve Stimulation 1 1
Irritation 1 1
Dyspnea 1 1
Erythema 1 1
Vessel Or Plaque, Device Embedded In 1 1
Abscess 1 1
Airway Obstruction 1 1
Exposure to Body Fluids 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Skin Burning Sensation 1 1
Unspecified Tissue Injury 1 1
Fluid Discharge 1 1
Bowel Perforation 1 1
Partial thickness (Second Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Electro Medical Systems SA II Apr-24-2024
2 Nakanishi Inc. II Aug-26-2016
3 Sonendo Inc II Nov-14-2022
4 Sonendo Inc II May-28-2020
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