TPLC - Total Product Life Cycle

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Device	handpiece, air-powered, dental
Regulation Description	Dental handpiece and accessories.
Product Code	EFB
Regulation Number	872.4200
Device Class	1

Premarket Reviews
Manufacturer	Decision
BEIJING DONGBO DENTAL HANDPIECE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN COXO MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN SOCO PRECISION INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN TOPMED DENTAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JAINTEK CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
LITU TECH , LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICROP TECHNOLOGY (TAIWAN), INC.
	SUBSTANTIALLY EQUIVALENT	1
NAKANISHI, INC.
	SUBSTANTIALLY EQUIVALENT	4
PAC-DENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
SAESHIN PRECISION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN CAREJOY TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TTBIO CORP.
	SUBSTANTIALLY EQUIVALENT	1
W&H DENTALWERK BÜRMOOS GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	298	903
Overheating of Device	194	1645
Mechanical Problem	42	42
Insufficient Information	17	17
Use of Device Problem	12	12
Improper or Incorrect Procedure or Method	9	9
Retraction Problem	9	9
Temperature Problem	9	9
Material Integrity Problem	9	9
Excessive Heating	8	8
Dent in Material	7	7
Adverse Event Without Identified Device or Use Problem	4	4
Unintended Electrical Shock	4	4
Misassembly by Users	4	4
Break	4	4
Accessory Incompatible	3	3
Component Incompatible	3	3
Entrapment of Device	3	3
Unintended Ejection	3	3
No Apparent Adverse Event	3	3
Physical Resistance/Sticking	3	3
Device Damaged by Another Device	3	3
Device Dislodged or Dislocated	3	3
Activation, Positioning or Separation Problem	2	2
Device Handling Problem	2	2
Loose or Intermittent Connection	2	2
Burst Container or Vessel	2	2
Material Separation	2	2
Inadequate Lubrication	2	2
Device Slipped	1	1
Material Puncture/Hole	1	1
Component Missing	1	1
Vibration	1	1
Noise, Audible	1	1
Premature Separation	1	1
Mechanical Jam	1	1
Defective Device	1	1
Patient-Device Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	448	2503
Burn(s)	112	1344
Foreign Body In Patient	50	50
Insufficient Information	40	502
Laceration(s)	15	15
Superficial (First Degree) Burn	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Partial thickness (Second Degree) Burn	5	5
Skin Tears	4	4
Abrasion	3	3
Choking	3	3
Local Reaction	2	2
Pain	2	2
Aspiration/Inhalation	1	1
Asthma	1	1
Tooth Fracture	1	1
Easy Bruising	1	1
Cough	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Coltene Whaledent Inc	II	Mar-02-2023