TPLC - Total Product Life Cycle

show TPLC since

Device	handpiece, air-powered, dental
Product Code	EFB
Regulation Number	872.4200
Device Class	1

Premarket Reviews
Manufacturer	Decision
BEIJING DONGBO DENTAL HANDPIECE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DENTALEZ, INC.
	SUBSTANTIALLY EQUIVALENT	1
DENTSPLY SIRONA
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN CICADA DENTAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN COXO MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN WENJIAN MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
J. MORITA USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
JAINTEK CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
KALTENBACH & VOIGT GMBH
	SUBSTANTIALLY EQUIVALENT	1
LITU TECH LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICROP TECHNOLOGY (TAIWAN), INC.
	SUBSTANTIALLY EQUIVALENT	1
NAKANISHI INC.
	SUBSTANTIALLY EQUIVALENT	3
NINGBO HPDOVE DENTAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
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	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	374	1270
Overheating of Device	174	1332
Mechanical Problem	43	43
Insufficient Information	15	15
Use of Device Problem	14	14
Device Handling Problem	9	9
Misassembly by Users	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Excessive Heating	7	7
Physical Resistance/Sticking	7	7
Dent in Material	6	6
Device Slipped	6	6
Retraction Problem	5	5
Improper or Incorrect Procedure or Method	5	5
Break	5	5
Temperature Problem	4	4
Unintended Electrical Shock	4	4
Defective Device	3	8
Device Dislodged or Dislocated	3	3
Accessory Incompatible	3	3
Component Incompatible	3	3
Entrapment of Device	3	3
Unintended Ejection	3	3
Fitting Problem	3	7
Material Separation	3	3
Loose or Intermittent Connection	2	2
Burst Container or Vessel	2	2
Device Reprocessing Problem	2	2
Activation, Positioning or Separation Problem	2	2
Inadequate Lubrication	2	2
Device Fell	2	2
Failure to Shut Off	1	1
Gas/Air Leak	1	1
Material Integrity Problem	1	1
Mechanical Jam	1	1
Noise, Audible	1	1
Premature Separation	1	1
Failure to Clean Adequately	1	1
Misassembly During Maintenance/Repair	1	1
Misassembled	1	1
Problem with Sterilization	1	1
Component Missing	1	1
Vibration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	372	1985
No Consequences Or Impact To Patient	131	579
Burn(s)	88	1082
Foreign Body In Patient	54	54
Insufficient Information	24	402
Burn, Thermal	10	10
Patient Problem/Medical Problem	10	10
No Known Impact Or Consequence To Patient	9	9
Injury	9	71
Laceration(s)	9	9
Tissue Damage	5	5
Superficial (First Degree) Burn	5	5
Pain	4	4
Choking	3	3
No Information	3	71
No Code Available	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Swelling	2	2
Scar Tissue	1	1
Pulmonary Emphysema	1	1
Hemorrhage/Bleeding	1	1
Abrasion	1	1
Air Embolism	1	1
Asthma	1	1
Skin Tears	1	1
Partial thickness (Second Degree) Burn	1	1
Cough	1	1
Chemical Exposure	1	1

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