TPLC - Total Product Life Cycle

show TPLC since

Device	resin, denture, relining, repairing, rebasing
Product Code	EBI
Regulation Number	872.3760
Device Class	2

Premarket Reviews
Manufacturer	Decision
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BELPORT COMPANY, INC., GINGI-PAK
	SUBSTANTIALLY EQUIVALENT	1
CLEMDE SA DE CV
	SUBSTANTIALLY EQUIVALENT	1
DELTAMED GMBH
	SUBSTANTIALLY EQUIVALENT	2
DENTAL DIREKT GMBH
	SUBSTANTIALLY EQUIVALENT	1
DENTCA, INC.
	SUBSTANTIALLY EQUIVALENT	1
DENTSPLY SIRONA
	SUBSTANTIALLY EQUIVALENT	3
DETAX GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
DIO CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
DK MUNGYO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
DREVE DENTAMID GMBH
	SUBSTANTIALLY EQUIVALENT	1
ENLIGHTEN MATERIALS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ENVISIONTEC GMBH
	SUBSTANTIALLY EQUIVALENT	1
GRAPHY INC.
	SUBSTANTIALLY EQUIVALENT	1
HARVEST DENTAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	2
IVOCLAR VIVADENT, INC
	SUBSTANTIALLY EQUIVALENT	1
MYERSON, LLC
	SUBSTANTIALLY EQUIVALENT	1
1. K230098 Trusana™
PAC-DENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRISMATIK DENTALCRAFT, INC.
	SUBSTANTIALLY EQUIVALENT	2
PRO3DURE MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG HUGE DENTAL MATERIAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
SPRINTRAY INC
	SUBSTANTIALLY EQUIVALENT	1
SPRINTRAY INC.
	SUBSTANTIALLY EQUIVALENT	2
STRATASYS LTD
	SUBSTANTIALLY EQUIVALENT	1
TOKUYAMA DENTAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VERTEX-DENTAL B.V.
	SUBSTANTIALLY EQUIVALENT	2
VERTEX-DENTAL BV
	SUBSTANTIALLY EQUIVALENT	1
VITA ZANHNFABRIK H. RAUTER GMBH CO.
	SUBSTANTIALLY EQUIVALENT	1
VOCO GMBH
	SUBSTANTIALLY EQUIVALENT	2
YAMAHACHI DENTAL MFG., CO.
	SUBSTANTIALLY EQUIVALENT	1
ZIRKONZAHN SRL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	20	20
Use of Device Problem	16	16
Improper or Incorrect Procedure or Method	14	14
Patient-Device Incompatibility	10	10
Device Handling Problem	3	3
Product Quality Problem	3	3
Break	1	1
Separation Failure	1	1
Difficult to Remove	1	1
Fracture	1	1
Device Appears to Trigger Rejection	1	1
Gas Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hypersensitivity/Allergic reaction	35	36
Burning Sensation	10	10
Rash	9	9
Skin Inflammation/ Irritation	8	8
Local Reaction	6	6
Localized Skin Lesion	5	5
Insufficient Information	5	5
Swelling	3	3
Discomfort	3	3
Peeling	3	3
Reaction	3	3
Swelling/ Edema	3	3
High Blood Pressure/ Hypertension	2	2
Nausea	2	2
Itching Sensation	2	2
Blister	2	2
Chest Pain	2	2
Dyspnea	2	2
Headache	2	2
Unspecified Infection	1	1
No Code Available	1	1
Inflammation	1	1
Asthma	1	1
Burn, Thermal	1	1
Chemical Exposure	1	1
Injury	1	1
Erythema	1	1
Pain	1	1
Unspecified Respiratory Problem	1	1
Airway Obstruction	1	1
Device Embedded In Tissue or Plaque	1	1