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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device powder, porcelain
Regulation Description Porcelain powder for clinical use.
Product CodeEIH
Regulation Number 872.6660
Device Class 2


Premarket Reviews
ManufacturerDecision
1DERFUL, INC.
  SUBSTANTIALLY EQUIVALENT 1
AIBODENT BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
AMANN GIRRBACH AG
  SUBSTANTIALLY EQUIVALENT 1
ANHUI MIISEN INTELLIGENCE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARGEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ARUM DENTISTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIODEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BLOOMDEN BIOCERAMICS (HUNAN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON MICRO FABRICATION
  SUBSTANTIALLY EQUIVALENT 1
CHANGSHA HONCHON TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHENGDU BESMILE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
DENKEN-HIGHDENTAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENMAT HOLDING, LLC
  SUBSTANTIALLY EQUIVALENT 1
DENTAL CREATIV MANAGEMENT GMBH
  SUBSTANTIALLY EQUIVALENT 1
DENTAL DIREKT GMBH
  SUBSTANTIALLY EQUIVALENT 1
DENTALMAX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 3
DMAX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DOCTUS GLOBAL
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN XIANGTONG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ESTETIC CERAM AG
  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 2
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 2
IVOCLAR VIVADENT, AG
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
KURARAY NORITAKE DENTAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
LIAONING RACHCERA MATERIAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIAONING UPCERA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 11
SHANDONG HUGE DENTAL MATERIAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN UP3D TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN XIANGTONG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN YURUCHENG DENTAL MATERIALS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHOFU DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TOPZIR BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNITED DENTAL RESOURCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
UNITED ZIRCONIA
  SUBSTANTIALLY EQUIVALENT 1
VATECH ACUCERA, INC.
  SUBSTANTIALLY EQUIVALENT 4
VATECH MCIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VERICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VITA ZAHNFABRIK H.RAUTER GMBH & CO.
  SUBSTANTIALLY EQUIVALENT 1
WHITEPEAKS DENTAL SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 3
YILINK (TIANJIN) BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIMA INTERNATIONAL INC., DBA DANDY
  SUBSTANTIALLY EQUIVALENT 1
ZIRDENT NEW MATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIRKONZAHN SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 22 25
2024 7 7
2025 1 1
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 18 18
Break 7 7
Appropriate Device Problem Term/Code Not Available 1 1
Loose or Intermittent Connection 1 1
Patient-Device Incompatibility 1 1

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 5 5
Implant Pain 2 2
Laceration(s) 2 2
Tooth Loss 2 2
Unspecified Tissue Injury 2 2
Blurred Vision 1 4
Fatigue 1 4
Pain 1 4
Sensitivity of Teeth 1 1
Hypersensitivity/Allergic reaction 1 1
Urticaria 1 4
Memory Loss/Impairment 1 4
Arthralgia 1 4
Dry Eye(s) 1 4
Unspecified Respiratory Problem 1 4
Fever 1 4
Hyperresponsive to stimuli 1 4
Abscess 1 1
Hair Loss 1 4

Recalls
Manufacturer Recall Class Date Posted
1 IVOCLAR VIVADENT AG II Apr-30-2024
2 Sagemax Bioceramics, Inc. II Jun-09-2026
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