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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 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 2
DIADENT GROUP INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
DMG CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
DOXA DENTAL AB
  SUBSTANTIALLY EQUIVALENT 1
GC AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 3
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
  SUBSTANTIALLY EQUIVALENT 2
KERR CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KETTENBACH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
KURARAY NORITAKE DENTAL INC.
  SUBSTANTIALLY EQUIVALENT 2
PARKELL, INC
  SUBSTANTIALLY EQUIVALENT 1
PREVEST DENPRO LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SDI LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SHOFU DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SPIDENT CO., LTD.
  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
2019 12 12
2020 5 5
2021 8 8
2022 3 3
2023 6 6
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 18 18
Increased Sensitivity 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Material Discolored 4 4
Unexpected Color 4 4
Loss of or Failure to Bond 2 2
Contamination 1 1
Product Quality Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Output Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Improper Chemical Reaction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 17 17
Pain 8 8
Insufficient Information 8 8
Sensitivity of Teeth 6 6
Swelling 3 3
Burning Sensation 2 2
Failure of Implant 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Chest Pain 1 1
Unspecified Infection 1 1
Inflammation 1 1
Irritation 1 1
Itching Sensation 1 1
Rash 1 1
Local Reaction 1 1
Increased Sensitivity 1 1
Skin Discoloration 1 1
Skin Irritation 1 1
Dysphasia 1 1
Reaction 1 1
Shaking/Tremors 1 1
No Known Impact Or Consequence To Patient 1 1
Localized Skin Lesion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Family Dollar Stores, Llc. II Nov-07-2023
2 Family Dollar Stores, Llc. II Aug-17-2022
3 Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical II Apr-29-2020
4 Preat Corp III Mar-06-2023
5 Voco GmbH II Feb-16-2024
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