TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
AJK ENGINEERING, INC.
	SUBSTANTIALLY EQUIVALENT	1
DENTALEZ, INC., STARDENTAL DIVISION
	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	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	472	473
Overheating of Device	356	356
Mechanical Problem	110	110
Output Problem	45	45
Temperature Problem	42	42
Therapeutic or Diagnostic Output Failure	36	36
Dent in Material	34	34
Physical Resistance/Sticking	26	26
Defective Device	23	23
Device Handling Problem	12	12
Break	11	11
Failure to Align	11	11
Mechanics Altered	9	9
Insufficient Information	9	11
Use of Device Problem	8	8
Computer Operating System Problem	7	7
Improper or Incorrect Procedure or Method	6	6
Incorrect Measurement	6	6
Device Slipped	6	6
Loose or Intermittent Connection	5	5
Noise, Audible	5	5
Data Problem	4	4
Material Separation	4	4
Unintended Collision	4	4
Calibration Problem	3	3
Mechanical Jam	3	3
Device Fell	2	2
Unintended Movement	2	2
Energy Output Problem	2	2
Entrapment of Device	2	2
Appropriate Term/Code Not Available	2	2
Unexpected Shutdown	2	2
Fitting Problem	2	2
Defective Component	1	1
Vibration	1	1
Unintended Ejection	1	1
Component Missing	1	1
Device Difficult to Maintain	1	1
Patient-Device Incompatibility	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Misconnection	1	1
Material Deformation	1	1
Intermittent Energy Output	1	1
Unintended Electrical Shock	1	1
Product Quality Problem	1	1
Retraction Problem	1	1
Excessive Heating	1	1
Failure to Cycle	1	1
Connection Problem	1	1
Human-Device Interface Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	525	528
Burn(s)	232	232
Partial thickness (Second Degree) Burn	89	89
Insufficient Information	83	83
No Consequences Or Impact To Patient	53	53
Superficial (First Degree) Burn	45	45
Patient Problem/Medical Problem	22	22
Burn, Thermal	22	22
Injury	19	19
No Known Impact Or Consequence To Patient	16	16
Foreign Body In Patient	12	12
Pain	8	8
Tooth Fracture	6	6
Laceration(s)	4	4
Device Embedded In Tissue or Plaque	4	4
Burning Sensation	3	3
No Information	2	2
Blister	2	2
Needle Stick/Puncture	2	2
Skin Tears	2	2
Skin Burning Sensation	2	2
Electric Shock	1	1
Unspecified Gastrointestinal Problem	1	1
Scar Tissue	1	1
Choking	1	1
Eye Injury	1	1
Ulceration	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Full thickness (Third Degree) Burn	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Young Dental Manufacturing I, LLC	II	Nov-09-2023