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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device powder, porcelain
Product CodeEIH
Regulation Number 872.6660
Device Class 2


Premarket Reviews
ManufacturerDecision
1DERFUL, INC
  SUBSTANTIALLY EQUIVALENT 1
3DBIOCAD
  SUBSTANTIALLY EQUIVALENT 1
AIBODENT BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
ANHUI MIISEN INTELLIGENCE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AON CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ARGEN CORPORATION
  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 3
DENTALMAX CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DENTALMAX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 3
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 2
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 CERAMASTER MATERIAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HUNAN HUALIAN SPECIAL CERAMICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN QINGHAO PUZHONG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN VSMILE BIOTECHNOLOGY CO., LTD
  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 RACHCERA MATERIAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIAONING UPCERA CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 10
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
WHITEPEAKS DENTAL SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 3
YILINK (TIANJIN) BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
YILINK (TIANJIN) BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
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
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 18 18
Break 4 4
Patient-Device Incompatibility 3 3
Material Integrity Problem 3 3
Device Contamination with Chemical or Other Material 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 21 21
Failure of Implant 19 19
No Clinical Signs, Symptoms or Conditions 4 4
Memory Loss/Impairment 2 2
Implant Pain 2 2
Pain 2 2
Unspecified Tissue Injury 2 2
Sleep Dysfunction 1 1
Urticaria 1 1
Tingling 1 1
Sweating 1 1
Arthralgia 1 1
Hypersensitivity/Allergic reaction 1 1
Fatigue 1 1
Inflammation 1 1
Dry Eye(s) 1 1
Palpitations 1 1
Confusion/ Disorientation 1 1
Alteration In Body Temperature 1 1
Fever 1 1
Cramp(s) 1 1
Discomfort 1 1
Hair Loss 1 1
Shaking/Tremors 1 1
Blurred Vision 1 1
Unspecified Respiratory Problem 1 1
Headache 1 1
Sensitivity of Teeth 1 1
Thyroid Problems 1 1
Increased Sensitivity 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
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