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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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
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
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

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 15 15
Adverse Event Without Identified Device or Use Problem 14 14
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
Device Appears to Trigger Rejection 1 1
Gas Output Problem 1 1
Separation Failure 1 1
Difficult to Remove 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 31 31
Burning Sensation 8 8
Skin Inflammation/ Irritation 8 8
Rash 7 7
Localized Skin Lesion 5 5
Insufficient Information 5 5
Local Reaction 5 5
Peeling 3 3
Swelling/ Edema 3 3
Discomfort 2 2
Dyspnea 2 2
Blister 2 2
Nausea 2 2
Chest Pain 2 2
Itching Sensation 2 2
Headache 2 2
Inflammation 1 1
Unspecified Respiratory Problem 1 1
Chemical Exposure 1 1
Device Embedded In Tissue or Plaque 1 1
Airway Obstruction 1 1
Asthma 1 1
Erythema 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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