TPLC - Total Product Life Cycle

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Device	handpiece, contra- and right-angle attachment, dental
Product Code	EGS
Regulation Number	872.4200
Device Class	1

Premarket Reviews
Manufacturer	Decision
AJK ENGINEERING, INC.
	SUBSTANTIALLY EQUIVALENT	1
ANGSTROM MFG., INC.
	SUBSTANTIALLY EQUIVALENT	2
ANTHOGYR SAS
	SUBSTANTIALLY EQUIVALENT	1
BONART CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DENTALEZ, INC
	SUBSTANTIALLY EQUIVALENT	1
DIRECTA AB
	SUBSTANTIALLY EQUIVALENT	1
ESSENTIAL DENTAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
HANDPIECE HEADQUARTERS
	SUBSTANTIALLY EQUIVALENT	2
J. MORITA USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
KAVO DENTAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
LARES RESEARCH
	SUBSTANTIALLY EQUIVALENT	1
MICRO-NX CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NAKANISHI INC.
	SUBSTANTIALLY EQUIVALENT	4
NAKANISHI, INC.
	SUBSTANTIALLY EQUIVALENT	1
PREMIUM PLUS INTERNATIONAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SAESHIN PRECISION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
SCICAN GMBH
	SUBSTANTIALLY EQUIVALENT	1
SIRONA DENTAL SYSTEMS GMBH
	SUBSTANTIALLY EQUIVALENT	1
THUNDER TIGER CORP.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	1288	1288
Detachment of Device or Device Component	591	592
Temperature Problem	212	212
Mechanical Problem	154	154
Detachment Of Device Component	107	107
Dent in Material	78	78
Insufficient Information	48	50
Output Problem	45	45
Therapeutic or Diagnostic Output Failure	43	43
Physical Resistance/Sticking	38	38
Defective Device	35	35
Loose or Intermittent Connection	30	30
Device Handling Problem	24	24
Failure To Service	22	22
Device Operates Differently Than Expected	20	20
Break	20	20
Improper or Incorrect Procedure or Method	15	15
Component Falling	14	14
Noise, Audible	13	13
Physical Property Issue	13	13
Use of Device Problem	13	13
Failure to Align	11	11
Device Maintenance Issue	10	10
Computer Operating System Problem	10	10
Mechanics Altered	9	9
Incorrect Measurement	8	8
Device Slipped	7	7
Retraction Problem	6	6
Material Separation	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Appropriate Term/Code Not Available	5	5
Data Problem	5	5
Device Dislodged or Dislocated	4	4
Mechanical Jam	3	3
Maintenance Does Not Comply To Manufacturers Recommendations	3	3
Device Damaged by Another Device	3	3
Entrapment of Device	3	3
Malposition of Device	3	3
Calibration Problem	3	3
Material Deformation	3	3
Component Missing	3	3
Defective Component	3	3
Device Fell	3	3
Unintended Movement	3	3
Fitting Problem	3	3
Corroded	2	2
Loss of Power	2	2
Energy Output Problem	2	2
Smoking	2	2
Disassembly	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	733	733
Burn(s)	531	531
No Clinical Signs, Symptoms or Conditions	523	526
Burn, Thermal	246	246
Injury	179	179
Patient Problem/Medical Problem	160	160
No Known Impact Or Consequence To Patient	160	160
Partial thickness (Second Degree) Burn	111	111
Insufficient Information	82	82
Superficial (First Degree) Burn	46	46
Foreign Body In Patient	33	33
No Information	20	20
Pain	17	17
No Patient Involvement	11	11
No Code Available	8	8
Burning Sensation	7	7
Laceration(s)	7	7
Swelling	6	6
Full thickness (Third Degree) Burn	5	5
Tooth Fracture	4	4
Device Embedded In Tissue or Plaque	4	4
Tissue Damage	3	3
Complaint, Ill-Defined	2	2
Blister	2	2
Needle Stick/Puncture	2	2
Numbness	2	2
Scar Tissue	2	2
Skin Tears	2	2
Erosion	2	2
Skin Burning Sensation	2	2
Electric Shock	1	1
Perforation	1	1
Scarring	1	1
Peeling	1	1
Eye Injury	1	1
Ulceration	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Hemorrhage/Bleeding	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Bien Air Dental SA	II	Sep-21-2015
2	Young Dental Manufacturing I, LLC	II	Nov-09-2023