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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
Product CodeEBI
Regulation Number 872.3760
Device Class 2


Premarket Reviews
ManufacturerDecision
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 3
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
MYERSON, LLC
  SUBSTANTIALLY EQUIVALENT 1
PAC-DENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRO3DURE MEDICAL GMBH
  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
TOKUYAMA DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VERTEX-DENTAL B.V.
  SUBSTANTIALLY EQUIVALENT 1
VERTEX-DENTAL BV
  SUBSTANTIALLY EQUIVALENT 1
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
2019 10 10
2020 8 8
2021 25 25
2022 2 2
2023 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 20 20
Use of Device Problem 16 16
Improper or Incorrect Procedure or Method 14 14
Patient-Device Incompatibility 10 10
Device Handling Problem 3 3
Product Quality Problem 3 3
Device Appears to Trigger Rejection 1 1
Difficult to Remove 1 1
Break 1 1
Fracture 1 1
Gas Output Problem 1 1
Separation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 34 35
Burning Sensation 10 10
Rash 9 9
Skin Inflammation/ Irritation 7 7
Local Reaction 6 6
Localized Skin Lesion 5 5
Insufficient Information 5 5
Reaction 3 3
Swelling 3 3
Discomfort 3 3
Peeling 3 3
Headache 2 2
Itching Sensation 2 2
Nausea 2 2
High Blood Pressure/ Hypertension 2 2
Chest Pain 2 2
Dyspnea 2 2
Blister 2 2
Swelling/ Edema 2 2
Burn, Thermal 1 1
Chemical Exposure 1 1
Device Embedded In Tissue or Plaque 1 1
No Code Available 1 1
Unspecified Respiratory Problem 1 1
Erythema 1 1
Airway Obstruction 1 1
Asthma 1 1
Unspecified Infection 1 1
Inflammation 1 1
Pain 1 1
Injury 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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