TPLC - Total Product Life Cycle

show TPLC since

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	2
PACIFIC CARE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
PREMIUM PLUS (DONGGUAN) LIMITED
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	360	361
Overheating of Device	340	340
Mechanical Problem	103	103
Incorrect Measurement	51	51
Device Handling Problem	47	47
Dent in Material	28	28
Temperature Problem	23	23
Physical Resistance/Sticking	17	17
Insufficient Device Problem Information	9	11
Use of Device Problem	5	5
Improper or Incorrect Procedure or Method	4	4
Unintended Collision	4	4
Calibration Problem	3	3
Mechanical Jam	2	2
Material Twisted/Bent	2	2
Break	2	2
Fracture	1	1
Human-Device Interface Problem	1	1
Device Difficult to Maintain	1	1
Patient-Device Incompatibility	1	1
Misassembly During Maintenance/Repair	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Noise, Audible	1	1
Material Separation	1	1
Material Deformation	1	1
Fluid/Blood Leak	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	508	511
Burn(s)	228	228
Partial thickness (Second Degree) Burn	135	135
Insufficient Information	130	130
Superficial (First Degree) Burn	47	47
Foreign Body In Patient	13	13
Pain	8	8
Tooth Fracture	6	6
Full thickness (Third Degree) Burn	5	5
Burn, Thermal	4	4
Device Embedded In Tissue or Plaque	4	4
Burning Sensation	3	3
Blister	2	2
Skin Burning Sensation	2	2
Needle Stick/Puncture	2	2
Laceration(s)	2	2
Electric Shock	1	1
Scar Tissue	1	1
Unspecified Gastrointestinal Problem	1	1
Eye Injury	1	1
Hypersensitivity/Allergic reaction	1	1
Choking	1	1
Swelling/ Edema	1	1

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