TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BELPORT COMPANY, INC., GINGI-PAK
	SUBSTANTIALLY EQUIVALENT	1
DENMAT HOLDING, LLC
	SUBSTANTIALLY EQUIVALENT	1
DIADENT GROUP INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	4
DMP DENTAL INDUSTRY S.A.
	SUBSTANTIALLY EQUIVALENT	1
GC AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	2
GENOSS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET AS
	SUBSTANTIALLY EQUIVALENT	1
IVOCLAR VIVADENT, AG
	SUBSTANTIALLY EQUIVALENT	1
KERR CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
KURARAY NORITAKE DENTAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIAONING UPCERA CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
MEDICLUS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
META BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PAC-DENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
PREVEST DENPRO LIMITED
	SUBSTANTIALLY EQUIVALENT	1
RELIANCE ORTHODONTIC PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	4
ROUNDING THIRD, LLC
	SUBSTANTIALLY EQUIVALENT	1
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITÄTEN GMBH
	SUBSTANTIALLY EQUIVALENT	1
SHOFU DENTAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SINCERA TECHNOLOGY (CHANGCHUN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SINO-DENTEX CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SPIDENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
TOKUYAMA DENTAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ULTRADENT PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	20	20
Improper or Incorrect Procedure or Method	8	8
Use of Device Problem	6	6
Adverse Event Without Identified Device or Use Problem	4	4
Patient Device Interaction Problem	2	2
Device Handling Problem	2	2
No Apparent Adverse Event	2	2
Improper Chemical Reaction	2	7
Component Missing	1	6
Product Quality Problem	1	1
Device Appears to Trigger Rejection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hypersensitivity/Allergic reaction	21	21
Caustic/Chemical Burns	8	8
Burning Sensation	5	5
Pain	5	5
Skin Inflammation/ Irritation	3	3
Burn(s)	3	3
Urticaria	2	2
Insufficient Information	2	7
Eye Injury	2	2
Skin Irritation	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Edema	1	1
Local Reaction	1	1
Blister	1	1
Rash	1	1
Swelling	1	1
Discomfort	1	1
Dyspnea	1	1
Cough	1	1
Deformity/ Disfigurement	1	1
Sensitivity of Teeth	1	1
Tissue Breakdown	1	1
Stomatitis	1	1