TPLC - Total Product Life Cycle

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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
E.M.S ELECTRO MEDICAL SYSTEMS S.A
	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
NAKANISHI, INC.
	SUBSTANTIALLY EQUIVALENT	2
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	1
W&H DENTALWERK BUERMOSS GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	473	473
Break	307	307
Restricted Flow rate	297	297
No Flow	258	258
Temperature Problem	35	35
Detachment of Device or Device Component	8	8
Insufficient Information	8	9
Excessive Heating	7	8
Unintended Electrical Shock	7	8
Power Problem	6	6
Fracture	6	6
Infusion or Flow Problem	5	5
Vibration	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Improper Flow or Infusion	4	4
Mechanical Problem	4	4
Material Fragmentation	3	3
Use of Device Problem	3	4
Component Missing	3	3
Patient-Device Incompatibility	3	3
Material Integrity Problem	2	2
Device Handling Problem	2	2
No Apparent Adverse Event	2	2
Melted	2	2
Therapeutic or Diagnostic Output Failure	1	1
Difficult to Remove	1	1
Patient Device Interaction Problem	1	1
Fail-Safe Problem	1	1
Material Twisted/Bent	1	1
Thermal Decomposition of Device	1	1
Material Puncture/Hole	1	1
Moisture or Humidity Problem	1	1
Complete Blockage	1	1
Lack of Effect	1	1
Product Quality Problem	1	1
Activation Problem	1	1
Output Problem	1	1
Separation Problem	1	1
Naturally Worn	1	1
Pressure Problem	1	1
Loose or Intermittent Connection	1	1
Improper or Incorrect Procedure or Method	1	1
Chemical Problem	1	1
Intermittent Loss of Power	1	1
Fluid/Blood Leak	1	1
Sparking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1089	1089
Insufficient Information	98	98
Burn(s)	19	20
Foreign Body In Patient	13	13
Laceration(s)	10	10
Device Embedded In Tissue or Plaque	10	10
Nerve Damage	4	4
Caustic/Chemical Burns	4	4
Hemorrhage/Bleeding	4	4
Superficial (First Degree) Burn	3	3
Numbness	3	3
Pain	3	4
Electric Shock	2	2
Sinus Perforation	2	2
Discomfort	2	2
Blurred Vision	2	2
Sensitivity of Teeth	2	2
Neuralgia	2	2
Increased Sensitivity	2	2
Dysphasia	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Burning Sensation	1	1
Undesired Nerve Stimulation	1	2
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