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	2
DENTALEZ, INC.
	SUBSTANTIALLY EQUIVALENT	2
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
MICROP TECHNOLOGY (TAIWAN), INC.
	SUBSTANTIALLY EQUIVALENT	2
NAKANISHI INC.
	SUBSTANTIALLY EQUIVALENT	2
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	361	1259
Overheating of Device	212	1240
Mechanical Problem	44	44
Use of Device Problem	13	13
Insufficient Information	12	12
Device Handling Problem	10	10
Improper or Incorrect Procedure or Method	8	8
Device Slipped	8	8
Detachment Of Device Component	8	8
Break	7	7
Physical Resistance/Sticking	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Misassembly by Users	7	7
Excessive Heating	6	6
Dent in Material	6	6
Temperature Problem	5	5
Device Maintenance Issue	4	4
Device Fell	4	4
Unintended Electrical Shock	4	4
Device Dislodged or Dislocated	4	4
Material Separation	4	4
Fitting Problem	4	8
Component Falling	4	4
Entrapment of Device	3	3
Unintended Ejection	3	3
Loose or Intermittent Connection	3	3
Defective Device	3	8
Activation, Positioning or Separation Problem	2	2
Maintenance Does Not Comply To Manufacturers Recommendations	2	2
Retraction Problem	2	2
Device Reprocessing Problem	2	2
Inadequate Lubrication	2	2
Premature Separation	1	1
Failure to Clean Adequately	1	1
Misassembly During Maintenance/Repair	1	1
Noise, Audible	1	1
Unintended Movement	1	1
Fail-Safe Design Failure	1	1
Component Incompatible	1	1
Use of Incorrect Control/Treatment Settings	1	1
Migration or Expulsion of Device	1	1
Misassembled	1	1
Accessory Incompatible	1	1
Material Fragmentation	1	1
Material Integrity Problem	1	1
Mechanical Jam	1	1
Failure to Shut Off	1	1
Gas/Air Leak	1	1
Component Missing	1	1
Vibration	1	1
Failure To Service	1	1
Problem with Sterilization	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	344	1829
No Consequences Or Impact To Patient	176	624
Burn(s)	93	963
Foreign Body In Patient	55	55
Insufficient Information	20	398
Burn, Thermal	19	19
No Known Impact Or Consequence To Patient	18	18
Patient Problem/Medical Problem	14	14
Injury	11	73
No Code Available	7	7
Superficial (First Degree) Burn	5	5
Laceration(s)	5	5
Tissue Damage	5	5
Swelling	3	3
Choking	3	3
No Information	3	71
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Pain	2	2
Scar Tissue	1	1
Pulmonary Emphysema	1	1
Hemorrhage/Bleeding	1	1
Abrasion	1	1
Air Embolism	1	1
Skin Tears	1	1
Chemical Exposure	1	1
Cough	1	1
Partial thickness (Second Degree) Burn	1	1

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