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U.S. Department of Health and Human Services

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


Premarket Reviews
ManufacturerDecision
BELPORT COMPANY, INC., GINGI-PAK
  SUBSTANTIALLY EQUIVALENT 1
BISCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
COSMEDENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
DIADENT GROUP INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
DMG CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
GC AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMICRYL DIS MALZEMELERI SANAYI VE TICARET AS
  SUBSTANTIALLY EQUIVALENT 2
KULZER, LLC
  SUBSTANTIALLY EQUIVALENT 1
KURARAY NORITAKE DENTAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OVERFIBERS S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
PARKELL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PREVEST DENPRO LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RIZHAO HUGE BIOMATERIALS COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 2
SDI LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SHOFU DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
SPIDENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 8 8
2022 3 3
2023 6 6
2024 5 5
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 14 14
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
Output Problem 1 1
Insufficient Information 1 1
Patient Device Interaction Problem 1 1
Improper Chemical Reaction 1 1
Improper or Incorrect Procedure or Method 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 12 12
Insufficient Information 8 8
Anaphylactoid 4 4
Burning Sensation 3 3
Sleep Dysfunction 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Arthralgia 2 2
Failure of Implant 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Atrial Fibrillation 2 2
Anxiety 2 2
Headache 2 2
Unspecified Infection 1 1
Necrosis 1 1
Skin Inflammation/ Irritation 1 1
Implant Pain 1 1
Itching Sensation 1 1
Localized Skin Lesion 1 1
Dyspnea 1 1
Swelling/ Edema 1 1
Hemorrhage/Bleeding 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 Preat Corp III Mar-06-2023
4 Voco GmbH II Feb-16-2024
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