• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device scaler, ultrasonic
Regulation Description Ultrasonic scaler.
Product CodeELC
Regulation Number 872.4850
Device Class 2


Premarket Reviews
ManufacturerDecision
CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
DENJOY DENTAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENT4YOU AG
  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
ODNE AG
  SUBSTANTIALLY EQUIVALENT 1
SATELEC-ACTEON GROUP
  SUBSTANTIALLY EQUIVALENT 1
SCHLUMBOHM GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MICRO ELECTRIC INTELLIGENCE CO., LTD.
  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
2020 164 164
2021 166 166
2022 165 165
2023 210 210
2024 219 219
2025 147 147

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 424 424
Break 335 335
Restricted Flow rate 253 253
No Flow 141 141
Temperature Problem 37 37
Insufficient Information 12 12
Infusion or Flow Problem 8 8
Excessive Heating 7 7
Detachment of Device or Device Component 7 7
Unintended Electrical Shock 6 6
Mechanical Problem 4 4
Fracture 4 4
Improper Flow or Infusion 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Patient-Device Incompatibility 3 3
Use of Device Problem 3 3
Component Missing 3 3
Fluid/Blood Leak 2 2
Melted 2 2
Material Integrity Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Difficult to Remove 2 2
Moisture or Humidity Problem 2 2
Improper or Incorrect Procedure or Method 1 1
Loose or Intermittent Connection 1 1
Naturally Worn 1 1
Power Problem 1 1
Product Quality Problem 1 1
Device Emits Odor 1 1
Lack of Effect 1 1
Insufficient Flow or Under Infusion 1 1
Thermal Decomposition of Device 1 1
Material Twisted/Bent 1 1
Obstruction of Flow 1 1
Fail-Safe Problem 1 1
Difficult to Insert 1 1
Material Fragmentation 1 1
Patient Device Interaction Problem 1 1
Defective Device 1 1
Complete Blockage 1 1
Activation Problem 1 1
Output Problem 1 1
Separation Problem 1 1
Pressure Problem 1 1
Chemical Problem 1 1
Sparking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 880 880
Insufficient Information 98 98
No Consequences Or Impact To Patient 95 95
Burn(s) 16 16
Foreign Body In Patient 13 13
No Known Impact Or Consequence To Patient 11 11
Device Embedded In Tissue or Plaque 11 11
Hemorrhage/Bleeding 5 5
Nerve Damage 4 4
Pain 4 4
Laceration(s) 4 4
Caustic/Chemical Burns 4 4
No Information 3 3
Sinus Perforation 3 3
Swelling 3 3
Numbness 3 3
Sensitivity of Teeth 3 3
Patient Problem/Medical Problem 2 2
Superficial (First Degree) Burn 2 2
Injury 2 2
No Patient Involvement 2 2
Discomfort 2 2
Blurred Vision 2 2
Neuralgia 2 2
Increased Sensitivity 2 2
Dysphasia 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Electric Shock 1 1
No Code Available 1 1
Burn, Thermal 1 1
Skin Discoloration 1 1
Burning Sensation 1 1
Dyspnea 1 1
Fluid Discharge 1 1
Undesired Nerve Stimulation 1 1
Unspecified Tissue Injury 1 1
Tinnitus 1 1
Skin Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Dental EZ Group Star Dental Division II Jun-24-2024
2 Electro Medical Systems SA II Apr-24-2024
3 Sonendo Inc II Nov-14-2022
4 Sonendo Inc II May-28-2020
-
-