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	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	1
W&H DENTALWERK BUERMOSS GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	442	442
Break	292	292
Restricted Flow rate	280	280
No Flow	220	220
Temperature Problem	34	34
Detachment of Device or Device Component	8	8
Unintended Electrical Shock	7	8
Excessive Heating	7	8
Insufficient Information	6	7
Fracture	5	5
Infusion or Flow Problem	5	5
Mechanical Problem	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	4
Component Missing	3	3
Melted	2	2
Material Integrity Problem	2	2
Fluid/Blood Leak	1	1
Intermittent Loss of Power	1	1
Improper or Incorrect Procedure or Method	1	1
Loose or Intermittent Connection	1	1
Naturally Worn	1	1
Power Problem	1	1
No Apparent Adverse Event	1	1
Product Quality Problem	1	1
Device Handling Problem	1	1
Lack of Effect	1	1
Moisture or Humidity Problem	1	1
Thermal Decomposition of Device	1	1
Material Twisted/Bent	1	1
Fail-Safe Problem	1	1
Battery Problem	1	1
Material Fragmentation	1	1
Patient Device Interaction Problem	1	1
Difficult to Remove	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Puncture/Hole	1	1
Complete Blockage	1	1
Activation Problem	1	1
Output Problem	1	1
High impedance	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	1005	1005
Insufficient Information	95	95
Burn(s)	16	17
Foreign Body In Patient	12	12
Device Embedded In Tissue or Plaque	9	9
Laceration(s)	5	5
Nerve Damage	4	4
Hemorrhage/Bleeding	4	4
Caustic/Chemical Burns	4	4
Numbness	3	3
Sensitivity of Teeth	2	2
Sinus Perforation	2	2
Discomfort	2	2
Neuralgia	2	2
Increased Sensitivity	2	2
Pain	2	3
Blurred Vision	2	2
Electric Shock	2	2
Superficial (First Degree) Burn	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Burning Sensation	1	1
Dysphasia	1	1
Tinnitus	1	1
Undesired Nerve Stimulation	1	2
Skin Burning Sensation	1	1
Unspecified Tissue Injury	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