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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cement, dental
Product CodeEMA
Regulation Number 872.3275
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
3M DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1
3M ESPE DENTAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BISCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSCARE LTDA
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
DOXA DENTAL AB
  SUBSTANTIALLY EQUIVALENT 1
GC AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 4
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
  SUBSTANTIALLY EQUIVALENT 1
ITENA CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
KERR CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KETTENBACH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
KURARAY NORITAKE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 2
META BIOMED CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
PARKELL, INC
  SUBSTANTIALLY EQUIVALENT 1
PREVEST DENPRO LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HUGE DENTAL MATERIAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 13 13
2018 4 4
2019 12 12
2020 5 5
2021 8 8
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 19 19
Adverse Event Without Identified Device or Use Problem 11 11
Appropriate Term/Code Not Available 6 6
Increased Sensitivity 6 6
Material Discolored 3 3
Unexpected Color 2 2
Loss of or Failure to Bond 1 1
Contamination 1 1
Hole In Material 1 1
Product Quality Problem 1 1
Use of Device Problem 1 1
Material Perforation 1 1
Output Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 17 17
Pain 9 9
Sensitivity of Teeth 7 7
No Code Available 7 7
Swelling 6 6
Insufficient Information 5 5
Inflammation 3 3
Dyspnea 2 2
Rash 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Skin Irritation 2 2
Reaction 2 2
Shaking/Tremors 1 1
Skin Tears 1 1
Tissue Breakdown 1 1
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1
Local Reaction 1 1
Increased Sensitivity 1 1
Skin Discoloration 1 1
Burning Sensation 1 1
Dysphasia 1 1
Osteolysis 1 1
Hemorrhage/Bleeding 1 1
Syncope 1 1
Chest Pain 1 1
Irritation 1 1
Peeling 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical II Apr-29-2020
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