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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 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 10
  1.  K191903  BruxZir GT (Gum Tissue) Color
  2.  K200131  BruxZir Steel
  3.  K213425  BruxZir Esthetic
  4.  K220816  BruxZir NOW
  5.  K220960  BruxZir Opaque Coloring Liquid
  6.  K230262  BruxZir™ Incisal Coloring Liquid
  7.  K231347  BruxZir™ TintEFX Coloring Liquid
  8.  K234014  Obsidian® NOW
  9.  K240574  BruxZir® Radiant
  10.  K240882  BruxZir® Esthetic
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
2024 2 2

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 19 19
Unspecified Tissue Injury 2 2
Implant Pain 2 2
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
Sensitivity of Teeth 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
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