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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 2
ASIGA PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
BELPORT COMPANY, INC., GINGI-PAK
  SUBSTANTIALLY EQUIVALENT 1
CLEMDE SA DE CV
  SUBSTANTIALLY EQUIVALENT 2
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
  SUBSTANTIALLY EQUIVALENT 1
DIO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ENVISIONTEC GMBH
  SUBSTANTIALLY EQUIVALENT 1
GRAPHY, INC.
  SUBSTANTIALLY EQUIVALENT 2
GUANGZHOU HEYGEARS IMC., 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
KAMEMIZU CHEMICAL INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KEYSTONE INDUSTRIES
  SUBSTANTIALLY EQUIVALENT 2
LUXCREO, INC.
  SUBSTANTIALLY EQUIVALENT 1
MYERSON, LLC
  SUBSTANTIALLY EQUIVALENT 1
PAC-DENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 4
STRATASYS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
VERTEX-DENTAL B.V.
  SUBSTANTIALLY EQUIVALENT 2
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 2
YAMAHACHI DENTAL MFG., CO.
  SUBSTANTIALLY EQUIVALENT 1
ZIRKONZAHN SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 25 25
2022 2 2
2023 13 13
2024 1 1
2025 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Expiration Date Error 18 18
Fracture 16 16
Adverse Event Without Identified Device or Use Problem 13 13
Improper or Incorrect Procedure or Method 13 13
Use of Device Problem 11 11
Patient-Device Incompatibility 6 6
Product Quality Problem 3 3
Break 1 1
Separation Failure 1 1
Difficult to Remove 1 1
Device Appears to Trigger Rejection 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 34 34
Hypersensitivity/Allergic reaction 28 28
Burning Sensation 8 8
Skin Inflammation/ Irritation 5 5
Local Reaction 5 5
Localized Skin Lesion 5 5
Insufficient Information 5 5
Rash 4 4
Peeling 3 3
Swelling/ Edema 3 3
Nausea 2 2
Blister 2 2
Chest Pain 2 2
Dyspnea 2 2
Headache 2 2
Inflammation 1 1
Asthma 1 1
Itching Sensation 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
4 STRATASYS LTD III Jul-07-2025
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