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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device resin, denture, relining, repairing, rebasing
Regulation Description Denture relining, repairing, or rebasing resin.
Product CodeEBI
Regulation Number 872.3760
Device Class 2


Premarket Reviews
ManufacturerDecision
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ASIGA PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
BELPORT COMPANY, INC., GINGI-PAK
  SUBSTANTIALLY EQUIVALENT 1
CLEMDE SA DE CV
  SUBSTANTIALLY EQUIVALENT 1
DELTAMED GMBH
  SUBSTANTIALLY EQUIVALENT 2
DENTAL DIREKT GMBH
  SUBSTANTIALLY EQUIVALENT 1
DENTCA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA INC.
  SUBSTANTIALLY EQUIVALENT 1
DETAX GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
DIO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
DK MUNGYO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DREVE DENTAMID GMBH
  SUBSTANTIALLY EQUIVALENT 1
ENLIGHTEN MATERIALS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ENVISIONTEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
GRAPHY INC.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU SHINING3D DENTAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HARVEST DENTAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
IVOCLAR VIVADENT, INC
  SUBSTANTIALLY EQUIVALENT 1
KEYSTONE INDUSTRIES
  SUBSTANTIALLY EQUIVALENT 1
MYERSON, LLC
  SUBSTANTIALLY EQUIVALENT 1
PAC-DENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 2
PRO3DURE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
RITON 3D TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG HUGE DENTAL MATERIAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SPRINTRAY INC
  SUBSTANTIALLY EQUIVALENT 1
SPRINTRAY INC.
  SUBSTANTIALLY EQUIVALENT 2
STRATASYS LTD
  SUBSTANTIALLY EQUIVALENT 1
VERTEX-DENTAL B.V.
  SUBSTANTIALLY EQUIVALENT 2
VITA ZANHNFABRIK H. RAUTER GMBH CO.
  SUBSTANTIALLY EQUIVALENT 1
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 2
YAMAHACHI DENTAL MFG., CO.
  SUBSTANTIALLY EQUIVALENT 1
ZIRKONZAHN SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 8 8
2021 25 25
2022 2 2
2023 13 13
2024 1 1
2025 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Expiration Date Error 18 18
Use of Device Problem 15 15
Adverse Event Without Identified Device or Use Problem 14 14
Fracture 13 13
Improper or Incorrect Procedure or Method 13 13
Patient-Device Incompatibility 5 5
Product Quality Problem 3 3
Device Handling Problem 2 2
Break 1 1
Separation Failure 1 1
Difficult to Remove 1 1
Device Appears to Trigger Rejection 1 1
Gas Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 31 31
No Clinical Signs, Symptoms or Conditions 30 30
Skin Inflammation/ Irritation 8 8
Burning Sensation 8 8
Rash 7 7
Local Reaction 5 5
Localized Skin Lesion 5 5
Insufficient Information 5 5
Peeling 3 3
Swelling/ Edema 3 3
Nausea 2 2
Itching Sensation 2 2
Blister 2 2
Chest Pain 2 2
Discomfort 2 2
Dyspnea 2 2
Headache 2 2
Inflammation 1 1
Asthma 1 1
Chemical Exposure 1 1
Erythema 1 1
Unspecified Respiratory Problem 1 1
Airway Obstruction 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Envisiontec US Llc II Feb-15-2022
2 GRAPHENANO DENTAL SL II Feb-28-2024
3 Keystone Industries II Sep-12-2023
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