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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device crown and bridge, temporary, resin
Product CodeEBG
Regulation Number 872.3770
Device Class 2


Premarket Reviews
ManufacturerDecision
3M DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
AMANN GIRRBACH AG
  SUBSTANTIALLY EQUIVALENT 1
ARUM DENTISTRY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BEGO BREMER GOLDSCHLAGEREI WILH. HERBST GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
BIOLOREN SRL
  SUBSTANTIALLY EQUIVALENT 1
BISCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
BLUE DENT DENTAL
  SUBSTANTIALLY EQUIVALENT 1
CANDULOR USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENDRES & METAUX SA
  SUBSTANTIALLY EQUIVALENT 1
DANVILLE MATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DELTAMED GMBH
  SUBSTANTIALLY EQUIVALENT 2
DENTAL DIREKT GMBH
  SUBSTANTIALLY EQUIVALENT 1
DENTALPLUS GMBH
  SUBSTANTIALLY EQUIVALENT 1
DENTCA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTIS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DETAX GMBH & CO.KG
  SUBSTANTIALLY EQUIVALENT 1
DIADENT GROUP INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
DMG CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
DMG USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DMP DENTAL INDUSTRY S.A.
  SUBSTANTIALLY EQUIVALENT 1
DREVE DENTAMID GMBH
  SUBSTANTIALLY EQUIVALENT 1
ENLIGHTEN MATERIALS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ENVISIONTEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
EXACTA DENTAL DIRECT, INC
  SUBSTANTIALLY EQUIVALENT 1
GC AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 1
GC AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU HEYGEARS IMC. INC
  SUBSTANTIALLY EQUIVALENT 1
HARVEST DENTAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
HUGE DENTAL MATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HULIANG(SHANGHAI) BIO-TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 3
KERR CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KETTENBACH GMBH & CO KG
  SUBSTANTIALLY EQUIVALENT 1
KTK MEDICAL SUPPLIES GMBH
  SUBSTANTIALLY EQUIVALENT 1
LANG DENTAL MFG. CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
META BIOMED CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MGNEWTON LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICERIUM S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
MYCONE DENTAL SUPPLY CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
NEO DENTAL CHEMICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEW STETIC S.A.
  SUBSTANTIALLY EQUIVALENT 1
NOVOCOL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PARKELL, INC.
  SUBSTANTIALLY EQUIVALENT 1
POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY
  SUBSTANTIALLY EQUIVALENT 1
PRO3DURE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
PULPDENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QUEST DENTAL USA CORP.
  SUBSTANTIALLY EQUIVALENT 2
RIZHAO HUGE DENTAL INDUSTRY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SCHUTZ-DENTAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SPIDENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TALLADIUM, INC.
  SUBSTANTIALLY EQUIVALENT 1
THE ARGEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
UNION DENTAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
VIPI INDUSTRIA,COMERCIO,EXPORTACAO E IMPORTACAO DE
  SUBSTANTIALLY EQUIVALENT 1
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 3
WHIP MIX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
YAMAHACHI DENTAL PRODUCTS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZEST ANCHORS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIRKONZAHN GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIRKONZAHN SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 23 23
2015 26 26
2016 1 1
2017 4 4
2019 6 6
2020 2 2
2021 4 4
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 23 23
Adverse Event Without Identified Device or Use Problem 12 12
Insufficient Information 12 12
Device Operates Differently Than Expected 4 4
Malposition of Device 4 4
Material Discolored 3 3
Fracture 2 2
Difficult To Position 2 2
Difficult to Remove 2 2
Inadequacy of Device Shape and/or Size 2 2
Defective Device 2 2
Break 2 2
Positioning Failure 2 2
Appropriate Term/Code Not Available 2 2
Material Integrity Problem 2 2
Patient Device Interaction Problem 1 1
Device-Device Incompatibility 1 1
Positioning Problem 1 1
Defective Component 1 1
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 23 23
Reaction 16 16
No Code Available 13 13
Swelling 8 8
Inflammation 5 5
Erythema 5 5
No Information 5 5
Failure of Implant 4 4
Pain 4 4
Irritation 3 3
Ulcer 3 3
Injury 2 2
Tissue Damage 2 2
Ulceration 2 2
Burning Sensation 2 2
Hemorrhage/Bleeding 2 2
Asthma 1 1
Burn(s) 1 1
Edema 1 1
Emotional Changes 1 1
Itching Sensation 1 1
Perforation 1 1
Respiratory Distress 1 1
Sedation 1 1
Blister 1 1
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Sinus Perforation 1 1
Urticaria 1 1
Complaint, Ill-Defined 1 1
Loss of consciousness 1 1
Obstruction/Occlusion 1 1
Sensitivity of Teeth 1 1
Nipple Ulceration 1 1
Iatrogenic Source 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Jeneric/Pentron II Dec-03-2009
2 Talladium Inc III Dec-01-2020
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