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TPLC
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Device
scaler, ultrasonic
Regulation Description
Ultrasonic scaler.
Product Code
ELC
Regulation Number
872.4850
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
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