TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ANGELUS INDUSTRIA DE PRODUTOS ODONTOLOGICOS S/A
	SUBSTANTIALLY EQUIVALENT	1
BEIJING C-ROOT DENTAL MEDICAL DEVICES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
DENTSPLY SIRONA, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIADENT GROUP INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	4
ENPUNO BIOTECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ENPUNO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ESSENTIAL DENTAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
GENOSS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INNOVATIVE BIOCERAMIX, INC.
	SUBSTANTIALLY EQUIVALENT	2
INTER-MED, INC.
	SUBSTANTIALLY EQUIVALENT	2
LONGLY BIOTECHNOLOGY (WUHAN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
LUMENDO AG
	SUBSTANTIALLY EQUIVALENT	1
MARUCHI
	SUBSTANTIALLY EQUIVALENT	3
MEDICLUS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
META BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
PREVEST DENPRO LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SEPTODONT
	SUBSTANTIALLY EQUIVALENT	2
SHIVA PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
SONENDO, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPIDENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SPRIG ORAL HEALTH TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ULTRADENT PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
VERICOM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VOCO GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Erosion	40	40
Patient-Device Incompatibility	20	22
Adverse Event Without Identified Device or Use Problem	13	15
Lack of Effect	12	12
Overfill	5	5
Patient Device Interaction Problem	5	5
Material Too Soft/Flexible	4	4
Material Integrity Problem	2	2
Insufficient Information	1	1
Failure to Align	1	1
Excess Flow or Over-Infusion	1	1
Packaging Problem	1	1
Unexpected Color	1	1
Material Protrusion/Extrusion	1	1
Component Misassembled	1	1
Appropriate Term/Code Not Available	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	42	42
Hypersensitivity/Allergic reaction	18	18
Pain	12	14
No Clinical Signs, Symptoms or Conditions	10	10
Swelling/ Edema	5	5
Unspecified Infection	4	4
Insufficient Information	3	3
Abscess	3	3
Rash	2	2
Discomfort	2	2
Necrosis	1	3
Inflammation	1	1
No Known Impact Or Consequence To Patient	1	1
Erythema	1	1
Osteolysis	1	1
Numbness	1	1
Caustic/Chemical Burns	1	1
No Consequences Or Impact To Patient	1	1
Tinnitus	1	1
Tissue Breakdown	1	3
Granuloma	1	1
Sensitivity of Teeth	1	1
Increased Sensitivity	1	1
Fistula	1	1