TPLC - Total Product Life Cycle

show TPLC since

Premarket Reviews
Manufacturer	Decision
CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
DENT4YOU AG
	SUBSTANTIALLY EQUIVALENT	1
E.M.S ELECTRO MEDICAL SYSTEMS S.A
	SUBSTANTIALLY EQUIVALENT	1
E.M.S ELECTRO MEDICAL SYSTEMS S.A.
	SUBSTANTIALLY EQUIVALENT	1
ENGINEERED ENDODONTICS
	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
SONENDO, INC.
	SUBSTANTIALLY EQUIVALENT	1
TTBIO CORP.
	SUBSTANTIALLY EQUIVALENT	2
W&H DENTALWERK BUERMOSS GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	523	523
Break	399	399
Restricted Flow rate	275	275
No Flow	96	96
Temperature Problem	42	42
Infusion or Flow Problem	14	14
Insufficient Information	9	9
Excessive Heating	7	7
Material Fragmentation	7	7
Unintended Electrical Shock	6	6
Improper Flow or Infusion	6	6
Detachment of Device or Device Component	5	5
Mechanical Problem	4	4
Fracture	4	4
Fluid/Blood Leak	3	3
Patient-Device Incompatibility	3	3
Defective Device	3	3
Therapeutic or Diagnostic Output Failure	3	3
Component Missing	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Melted	2	2
Difficult to Remove	2	2
Ejection Problem	2	2
Power Problem	2	2
Device Emits Odor	2	2
Moisture or Humidity Problem	2	2
Loose or Intermittent Connection	1	1
Electrical /Electronic Property Problem	1	1
Naturally Worn	1	1
Product Quality Problem	1	1
Insufficient Flow or Under Infusion	1	1
Decrease in Pressure	1	1
Thermal Decomposition of Device	1	1
Material Twisted/Bent	1	1
Obstruction of Flow	1	1
Use of Device Problem	1	1
Difficult to Insert	1	1
Material Integrity Problem	1	1
Vibration	1	1
Smoking	1	1
Complete Blockage	1	1
Activation Problem	1	1
Output Problem	1	1
Separation Problem	1	1
Sparking	1	1
Leak/Splash	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	734	734
No Consequences Or Impact To Patient	362	362
Insufficient Information	95	95
No Known Impact Or Consequence To Patient	31	31
No Information	21	21
Burn(s)	14	14
Foreign Body In Patient	14	14
Device Embedded In Tissue or Plaque	13	13
Injury	4	4
Pain	4	4
Needle Stick/Puncture	3	3
Swelling	3	3
Numbness	3	3
Laceration(s)	3	3
Sensitivity of Teeth	3	3
Superficial (First Degree) Burn	2	2
Patient Problem/Medical Problem	2	2
Burn, Thermal	2	2
No Patient Involvement	2	2
Hemorrhage/Bleeding	2	2
Tinnitus	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
Bowel Perforation	1	1
Sinus Perforation	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
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