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	295	900
Overheating of Device	180	1579
Mechanical Problem	41	41
Insufficient Information	17	17
Use of Device Problem	12	12
Material Integrity Problem	9	9
Retraction Problem	9	9
Temperature Problem	9	9
Excessive Heating	8	8
Improper or Incorrect Procedure or Method	8	8
Dent in Material	7	7
Break	4	4
Unintended Electrical Shock	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Misassembly by Users	4	4
Entrapment of Device	3	3
Physical Resistance/Sticking	3	3
Accessory Incompatible	3	3
Unintended Ejection	3	3
Device Damaged by Another Device	3	3
No Apparent Adverse Event	3	3
Device Dislodged or Dislocated	3	3
Component Incompatible	3	3
Activation, Positioning or Separation Problem	2	2
Burst Container or Vessel	2	2
Inadequate Lubrication	2	2
Material Separation	2	2
Loose or Intermittent Connection	2	2
Device Slipped	1	1
Material Puncture/Hole	1	1
Patient-Device Incompatibility	1	1
Vibration	1	1
Defective Device	1	1
Component Missing	1	1
Device Handling Problem	1	1
Premature Separation	1	1
Mechanical Jam	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	434	2437
Burn(s)	108	1314
Foreign Body In Patient	49	49
Insufficient Information	38	500
Laceration(s)	15	15
Superficial (First Degree) Burn	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Skin Tears	4	4
Partial thickness (Second Degree) Burn	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