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	444	444
Restricted Flow rate	301	301
No Flow	261	261
Break	210	210
Insufficient Device Problem Information	10	11
Detachment of Device or Device Component	8	8
Unintended Electrical Shock	6	6
Vibration	5	5
Power Problem	5	5
Fracture	5	5
Temperature Problem	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Material Fragmentation	3	3
Excessive Heating	3	4
Material Integrity Problem	2	2
Use of Device Problem	2	3
No Apparent Adverse Event	2	2
Device Handling Problem	2	2
Infusion or Flow Problem	1	1
Intermittent Loss of Power	1	1
Improper Flow or Infusion	1	1
Complete Blockage	1	1
Mechanical Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Lack of Effect	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1116	1116
Insufficient Information	98	98
Burn(s)	19	20
Foreign Body In Patient	13	13
Device Embedded In Tissue or Plaque	10	10
Laceration(s)	10	10
Pain	5	6
Sinusitis	4	4
Hemorrhage/Blood Loss/Bleeding	4	4
Caustic/Chemical Burns	4	4
Discomfort	4	4
Nerve Damage	4	4
Superficial (First Degree) Burn	3	3
Numbness	3	3
Inflammation	2	2
Sinus Perforation	2	2
Sensitivity of Teeth	2	2
Blurred Vision	2	2
Hyperresponsive to stimuli	2	2
Neuralgia	2	2
Electric Shock	2	2
Swelling/ Edema	2	2
Burning Sensation	1	1
Undesired Nerve Stimulation	1	2
Unspecified Tissue Injury	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Dysphasia	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