TPLC - Total Product Life Cycle

• Device: powder, porcelain
• Product Code: EIH
• Regulation Number: 872.6660
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
1DERFUL, INC
	SUBSTANTIALLY EQUIVALENT	1
3DBIOCAD
	SUBSTANTIALLY EQUIVALENT	1
AIBODENT BIOTECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
AON CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ARUMDENTISTRY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BAOT BIOLOGICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BESORAH DENTAL SOLUTIONS NZ LIMITED
	SUBSTANTIALLY EQUIVALENT	1
BIODEN CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BLOOMDEN BIOCERAMICS (HUNAN) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BOSTON MICRO FABRICATION
	SUBSTANTIALLY EQUIVALENT	1
CENDRES+METAUX SA
	SUBSTANTIALLY EQUIVALENT	1
CHANGSHA HONCHON TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CHENGDU BESMILE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
DE COREMATRIX CO.LTD.
	SUBSTANTIALLY EQUIVALENT	1
DENKEN-HIGHDENTAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DENTAL DIREKT GMBH
	SUBSTANTIALLY EQUIVALENT	2
DENTALMAX CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DENTSPLY SIRONA
	SUBSTANTIALLY EQUIVALENT	1
DIGITAL AGE DENTAL LAB
	SUBSTANTIALLY EQUIVALENT	1
DOCTUS GLOBAL
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN XIANGTONG CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
FINE ADVANCED COMPOUND CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
FUZHOU RICK BROWN BIOMATERIALS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GENOSS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU IVISTA MEDICAL DEVICES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HARVEST DENTAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
HASS CORP.
	SUBSTANTIALLY EQUIVALENT	1
HOCHENG CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
HUNAN VSMILE BIOTECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
IVOCLAR VIVADENT AG
	SUBSTANTIALLY EQUIVALENT	1
JENSEN INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
KURARAY NORITAKE DENTAL INC.
	SUBSTANTIALLY EQUIVALENT	4
LIAONING UPCERA CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
OSSTEM IMPLANT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PRISMATIK DENTALCRAFT, INC.
	SUBSTANTIALLY EQUIVALENT	9
QINHUANGDAO AUDENTAL METAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN UP3D TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN XIANGTONG CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN YURUCHENG DENTAL MATERIALS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
SHOFU DENTAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
THE ARGEN CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
TOPZIR BIOTECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
U&C INTERNATIONAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
UNITED DENTAL RESOURCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
VATECH ACUCERA, INC.
	SUBSTANTIALLY EQUIVALENT	4
VATECH MCIS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VERICOM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VITA ZAHNFABRIK GMBH H RAUTER & CO
	SUBSTANTIALLY EQUIVALENT	2
YILINK (TIANJIN) BIOTECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
ZIRDENT NEW MATERIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZIRKONZAHN SRL
	SUBSTANTIALLY EQUIVALENT	3
ZMAXX BIOCERAMICS LLC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	1	1
2021	22	22

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	18	18
Device Contamination with Chemical or Other Material	3	3
Material Integrity Problem	3	3
Patient-Device Incompatibility	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	21	21
Failure of Implant	18	18
Memory Loss/Impairment	2	2
Pain	2	2
Thyroid Problems	1	1
Blurred Vision	1	1
Tingling	1	1
Cramp(s)	1	1
Urticaria	1	1
Discomfort	1	1
Arthralgia	1	1
Sweating	1	1
Palpitations	1	1
Shaking/Tremors	1	1
Sleep Dysfunction	1	1
Confusion/ Disorientation	1	1
Alteration In Body Temperature	1	1
Unspecified Respiratory Problem	1	1
Increased Sensitivity	1	1
Inflammation	1	1
Dry Eye(s)	1	1
Fatigue	1	1
Fever	1	1
Hair Loss	1	1
Headache	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	IVOCLAR VIVADENT AG	II	Apr-30-2024
2	Ivoclar Vivadent AG	II	May-01-2020
3	Talladium Inc	II	Sep-09-2020