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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
3DBIOCAD
  SUBSTANTIALLY EQUIVALENT 1
3M DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1
ADAMANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AESTHETIC-PRESS, LLC
  SUBSTANTIALLY EQUIVALENT 1
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
AMANN GIRRBACH AG
  SUBSTANTIALLY EQUIVALENT 1
AMS
  SUBSTANTIALLY EQUIVALENT 1
AON 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
BLUE SKY BIO
  SUBSTANTIALLY EQUIVALENT 1
CCRI, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENDRES+METAUX SA
  SUBSTANTIALLY EQUIVALENT 1
CHENGDU BESMILE BIOTECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
CROWN PORCELAIN DENTAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DE COREMATRIX CO.LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTAL DIREKT GMBH
  SUBSTANTIALLY EQUIVALENT 3
DENTALMAX CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 3
DIGITAL AGE DENTAL LAB
  SUBSTANTIALLY EQUIVALENT 1
DMAX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN XIANGTONG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FINE ADVANCED COMPOUND CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GC AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 3
GENOSS
  SUBSTANTIALLY EQUIVALENT 3
GENOSS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENOSS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU ERRAN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HASS CORP.
  SUBSTANTIALLY EQUIVALENT 2
HOCHENG CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INSTITUT STRAUMANN AG
  SUBSTANTIALLY EQUIVALENT 3
IVOCLAR VIVADENT AG
  SUBSTANTIALLY EQUIVALENT 2
JENSEN INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
KURARAY NORITAKE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 4
LIAONING UPCERA CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MAXX DIGM, INC.
  SUBSTANTIALLY EQUIVALENT 1
METOXIT AG
  SUBSTANTIALLY EQUIVALENT 1
NISSIN-METEC CHINA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OPERART LLC
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 3
PRITIDENTA GMBH
  SUBSTANTIALLY EQUIVALENT 1
QINHUANGDAO AUDENTAL METAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
QINHUANGDAO SILIDE CERAMIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
RHONDIUM, LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI NEW CENTURY DENTAL MATERIALS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN XIANGTONG PHOTOELECTRICITY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHOFU DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
SIRONA DENTAL SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1
TALLADIUM, INC.
  SUBSTANTIALLY EQUIVALENT 1
THE ARGEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
U&C INTERNATIONAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNITED DENTAL RESOURCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
VATECH ACUCERA, INC.
  SUBSTANTIALLY EQUIVALENT 3
VERICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VITA ZAHNFABRIK GMBH H RAUTER & CO
  SUBSTANTIALLY EQUIVALENT 2
VITA ZAHNFABRIK H.RAUTER GMBH CO.
  SUBSTANTIALLY EQUIVALENT 1
YETI DENTALPRODUKTE GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIRDENT NEW MATERIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIRKONZAHN SRL
  SUBSTANTIALLY EQUIVALENT 2
ZMAXX BIOCERAMICS LLC
  SUBSTANTIALLY EQUIVALENT 1
ZXTGY (BEIJING) TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 4 4
2017 1 1
2018 2 2
2019 1 1
2021 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 20 20
Patient-Device Incompatibility 3 3
Material Integrity Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Insufficient Information 2 2
Break 1 1
Device Handling Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 21 21
Failure of Implant 18 18
Pain 4 4
Reaction 3 3
Memory Loss/Impairment 2 2
Complaint, Ill-Defined 2 2
Arthralgia 1 1
Inflammation 1 1
Dry Eye(s) 1 1
Fatigue 1 1
Fever 1 1
Hair Loss 1 1
Headache 1 1
Hypersensitivity/Allergic reaction 1 1
Red Eye(s) 1 1
Swelling 1 1
Thyroid Problems 1 1
Blurred Vision 1 1
Burning Sensation 1 1
Tingling 1 1
Cramp(s) 1 1
Urticaria 1 1
Discomfort 1 1
Sweating 1 1
Palpitations 1 1
Shaking/Tremors 1 1
Sleep Dysfunction 1 1
Confusion/ Disorientation 1 1
No Patient Involvement 1 1
Alteration In Body Temperature 1 1
No Known Impact Or Consequence To Patient 1 1
Unspecified Respiratory Problem 1 1
Increased Sensitivity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ivoclar Vivadent AG II May-01-2020
2 Ivoclar Vivadent, Inc. II Oct-04-2016
3 Prismatik Dentalcraft, Inc II Sep-27-2016
4 Talladium Inc II Sep-09-2020
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