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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
3M DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1
3M ESPE AG
  SUBSTANTIALLY EQUIVALENT 2
3M ESPE AG DENTAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
A & D DENTAL INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
A&E BIOCERAMIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ADAMANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AESTHETIC-PRESS, LLC
  SUBSTANTIALLY EQUIVALENT 1
AIBODENT BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
AMANN GIRRBACH AG
  SUBSTANTIALLY EQUIVALENT 1
AMS
  SUBSTANTIALLY EQUIVALENT 1
AMS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ANHUI MIISEN INTELLIGENCE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AON CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ARDENT INC
  SUBSTANTIALLY EQUIVALENT 1
ARUMDENTISTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
B&D DENTAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
BAOT BIOLOGICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
  SUBSTANTIALLY EQUIVALENT 2
BESORAH DENTAL SOLUTIONS NZ LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BETTINI S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
BIODEN CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BIODENTA SWISS AG
  SUBSTANTIALLY EQUIVALENT 1
BK MEDENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BLOOMDEN BIOCERAMICS (HUNAN) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BLUE SKY BIO
  SUBSTANTIALLY EQUIVALENT 1
BOSTON MICRO FABRICATION
  SUBSTANTIALLY EQUIVALENT 1
CCRI, INC.
  SUBSTANTIALLY EQUIVALENT 2
CENDRES+METAUX SA
  SUBSTANTIALLY EQUIVALENT 1
CERAMAY GMBH & CO.KG
  SUBSTANTIALLY EQUIVALENT 1
CHANGSHA HONCHON TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CHENGDU BESMILE BIOTECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHENGDU BESMILE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
COHO TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CONTINENTAL DENTAL CERAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTINENTAL DENTAL CERAMICS, INC. (DBA CONTINENTAL
  SUBSTANTIALLY EQUIVALENT 1
CROWN PORCELAIN DENTAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DE COREMATRIX CO.LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENKEN-HIGHDENTAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTAIM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTAL DIREKT GMBH
  SUBSTANTIALLY EQUIVALENT 4
DENTAL DIREKT OF AMERIKA UG (HAFTUNGSBESCHRAENKT)
  SUBSTANTIALLY EQUIVALENT 2
DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS)
  SUBSTANTIALLY EQUIVALENT 1
DENTAL MILLING LABORATORY SUPPLIES (DLMS)
  SUBSTANTIALLY EQUIVALENT 1
DENTAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTALMAX CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DENTALMAX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
DENTSPLY INTL.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 3
DIGITAL AGE DENTAL LAB
  SUBSTANTIALLY EQUIVALENT 1
DMAX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DOCERAM MEDICAL CERAMICS GMBH
  SUBSTANTIALLY EQUIVALENT 1
DOCTUS GLOBAL
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN XIANGTONG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DR SARAH POLLINGTON
  SUBSTANTIALLY EQUIVALENT 1
EMERGO EUROPE CONSULTING
  SUBSTANTIALLY EQUIVALENT 1
FINE ADVANCED COMPOUND CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
FUZHOU RICK BROWN BIOMATERIALS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GC AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 4
GENOSS
  SUBSTANTIALLY EQUIVALENT 5
GENOSS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENOSS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
H.C. STARCK CERAMICS GMBH
  SUBSTANTIALLY EQUIVALENT 3
HANGZHOU ERRAN TECHNOLOGY 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 4
HEANY INDUSTRIES INC
  SUBSTANTIALLY EQUIVALENT 1
HILLA TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOCHENG CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HUNAN CERAMASTER MATERIAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HUNAN VSMILE BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
INSTITUT STRAUMANN AG
  SUBSTANTIALLY EQUIVALENT 3
IVOCLAR VIVADENT AG
  SUBSTANTIALLY EQUIVALENT 5
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
JENSEN INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
JYOTI CERAMIC INDUSTRIES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
KEROX LTD
  SUBSTANTIALLY EQUIVALENT 1
KURARAY NORITAKE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 9
KURARAY NORITAKE DENTAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KUWOTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
LIAONING UPCERA CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
LIAONING UPCERA CO.,LTD
  SUBSTANTIALLY EQUIVALENT 4
MAXX DIGM, INC.
  SUBSTANTIALLY EQUIVALENT 1
METOXIT AG
  SUBSTANTIALLY EQUIVALENT 1
NEO GROUP LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NISSIN-METEC CHINA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE AB
  SUBSTANTIALLY EQUIVALENT 1
NORITAKE CO., INC.
  SUBSTANTIALLY EQUIVALENT 2
OPERART LLC
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 17
PRITIDENTA GMBH
  SUBSTANTIALLY EQUIVALENT 1
QINHUANGDAO AIDITE HIGH-TECHNICAL CERAMICS CO, LTD
  SUBSTANTIALLY EQUIVALENT 1
QINHUANGDAO AUDENTAL METAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
QINHUANGDAO SILIDE CERAMIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
REFRACTRON TECHNOLOGIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
RHONDIUM, LTD
  SUBSTANTIALLY EQUIVALENT 1
RIZHAO HUGE DENTAL INDUSTRY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SAGEMAX BIOCERAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI NEW CENTURY DENTAL MATERIALS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENYANG UPCERA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN UP3D TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN XIANGTONG CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN XIANGTONG PHOTOELECTRICITY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN YURUCHENG DENTAL MATERIALS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHOFU DENTAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
SHOFU DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
SIRONA DENTAL SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 4
SOMERSET DENTAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TALLADIUM, INC.
  SUBSTANTIALLY EQUIVALENT 5
TANAKA DENTAL
  SUBSTANTIALLY EQUIVALENT 1
THE ARGEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
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
VITA ZAHNFABRIK H. RAUTER GMBH & CO.
  SUBSTANTIALLY EQUIVALENT 4
VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG.
  SUBSTANTIALLY EQUIVALENT 1
VITA ZAHNFABRIK H.RAUTER GMBH CO.
  SUBSTANTIALLY EQUIVALENT 1
WHIP MIX CORP.
  SUBSTANTIALLY EQUIVALENT 1
WHIP MIX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
WIELAND DENTAL + TECHNIK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 6
XCERAMUSA
  SUBSTANTIALLY EQUIVALENT 1
YETI DENTALPRODUKTE GMBH
  SUBSTANTIALLY EQUIVALENT 1
YILINK (TIANJIN) BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
ZENCERA INC
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIRDENT NEW MATERIAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIRKONZAHN GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIRKONZAHN SRL
  SUBSTANTIALLY EQUIVALENT 4
ZMAXX BIOCERAMICS LLC
  SUBSTANTIALLY EQUIVALENT 1
ZXTGY (BEIJING) TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2016 4 4
2017 1 1
2018 2 2
2019 1 1
2021 22 22
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 20 20
Patient-Device Incompatibility 4 4
Device Contamination with Chemical or Other Material 3 3
Material Integrity Problem 3 3
Insufficient Information 2 2
Device Handling Problem 1 1
Break 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 19 19
Pain 4 4
Reaction 3 3
Complaint, Ill-Defined 2 2
Unspecified Tissue Injury 2 2
Implant Pain 2 2
Hypersensitivity/Allergic reaction 2 2
Memory Loss/Impairment 2 2
Inflammation 1 1
Diarrhea 1 1
Dry Eye(s) 1 1
Fatigue 1 1
Fever 1 1
Hair Loss 1 1
Headache 1 1
Red Eye(s) 1 1
Swelling 1 1
Thyroid Problems 1 1
Blurred Vision 1 1
Vomiting 1 1
Burning Sensation 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
Abdominal Cramps 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 Apr-30-2024
2 Ivoclar Vivadent AG II May-01-2020
3 Ivoclar Vivadent, Inc. II Oct-04-2016
4 Ivoclar Vivadent, Inc. II Jul-27-2015
5 Prismatik Dentalcraft, Inc II Sep-27-2016
6 Talladium Inc II Sep-09-2020
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