TPLC - Total Product Life Cycle

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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
E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN CICADA DENTAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN WENJIAN MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
J. MORITA USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
KALTENBACH & VOIGT GMBH
	SUBSTANTIALLY EQUIVALENT	1
MICROP TECHNOLOGY (TAIWAN), INC.
	SUBSTANTIALLY EQUIVALENT	2
NAKANISHI, INC.
	SUBSTANTIALLY EQUIVALENT	1
NINGBO HPDOVE DENTAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PREMIUM PLUS INTERNATIONAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
TTBIO CORP.
	SUBSTANTIALLY EQUIVALENT	1
W & H DENTALWERK BUERMOOS GMBH
	SUBSTANTIALLY EQUIVALENT	1
W&H DENTALWERK BURMOOS GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	281	948
Detachment of Device or Device Component	252	888
Detachment Of Device Component	39	39
Mechanical Problem	32	32
Use of Device Problem	11	11
Improper or Incorrect Procedure or Method	10	10
Device Slipped	10	10
Device Handling Problem	10	10
Device Maintenance Issue	8	8
Break	7	7
Dent in Material	7	7
Physical Resistance/Sticking	7	7
Maintenance Does Not Comply To Manufacturers Recommendations	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Component Falling	5	5
Unintended Ejection	5	5
Migration or Expulsion of Device	4	4
Device Operates Differently Than Expected	4	4
Device Dislodged or Dislocated	4	4
Material Separation	4	4
Fitting Problem	4	8
Device Fell	4	4
Misassembly by Users	4	4
Insufficient Information	3	3
Defective Device	3	8
Temperature Problem	3	3
Loose or Intermittent Connection	3	3
Entrapment of Device	3	3
Device Reprocessing Problem	2	2
Failure To Service	2	2
Activation, Positioning or SeparationProblem	2	2
Premature Separation	1	1
Failure to Clean Adequately	1	1
Misassembly During Maintenance/Repair	1	1
Noise, Audible	1	1
Inadequate Service	1	1
Problem with Sterilization	1	1
Vibration	1	1
Unintended Movement	1	1
Failure to Shut Off	1	1
Gas Leak	1	1
Lack of Maintenance Documentation or Guidelines	1	1
Fail-Safe Design Failure	1	1
Use of Incorrect Control Settings	1	1
Disassembly	1	1
Material Fragmentation	1	1
Misassembled	1	1
Retraction Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	284	732
No Clinical Signs, Symptoms or Conditions	182	1045
Burn(s)	77	603
Foreign Body In Patient	55	55
No Known Impact Or Consequence To Patient	28	28
Burn, Thermal	23	23
Patient Problem/Medical Problem	21	21
Injury	14	76
No Code Available	10	10
Insufficient Information	8	269
Tissue Damage	6	6
No Information	5	73
Superficial (First Degree) Burn	3	3
Swelling	3	3
Laceration(s)	3	3
Tooth Fracture	3	3
Choking	2	2
Pain	2	2
Partial thickness (Second Degree) Burn	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Cough	1	1
Scar Tissue	1	1
Pulmonary Emphysema	1	1
Hemorrhage/Bleeding	1	1
Abrasion	1	1
Air Embolism	1	1
Airway Obstruction	1	1
Chemical Exposure	1	1