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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
Product CodeEBI
Regulation Number 872.3760
Device Class 2


Premarket Reviews
ManufacturerDecision
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BISCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLEMDE SA DE CV
  SUBSTANTIALLY EQUIVALENT 1
CMP INDUSTRIES LLC
  SUBSTANTIALLY EQUIVALENT 1
COMFORT AND FLEXIBLE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
DELTAMED GMBH
  SUBSTANTIALLY EQUIVALENT 2
DENTAL DIREKT GMBH
  SUBSTANTIALLY EQUIVALENT 1
DENTAL SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DENTCA, INC.
  SUBSTANTIALLY EQUIVALENT 3
DENTSOLL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 5
DETAX GMBH & CO. KG
  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
GC AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL DENTAL SCIENCE
  SUBSTANTIALLY EQUIVALENT 1
GRAPHY INC.
  SUBSTANTIALLY EQUIVALENT 1
GREAT LAKES ORTHODONTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
HARVEST DENTAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
HERAEUS KULZER, LLC
  SUBSTANTIALLY EQUIVALENT 2
IVOCLAR VIVADENT, INC
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
JUELL DENTAL
  SUBSTANTIALLY EQUIVALENT 2
JUVORA
  SUBSTANTIALLY EQUIVALENT 2
JUVORA, LTD.
  SUBSTANTIALLY EQUIVALENT 1
KOREA ENGINEERING PLASTICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LANG DENTAL MANUFACTURING CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
LANG DENTAL MANUFACTURING COMPANY, INC
  SUBSTANTIALLY EQUIVALENT 1
LANG DENTAL MFG. CO., INC.
  SUBSTANTIALLY EQUIVALENT 2
MERZ DENTAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
MYCONE DENTAL SUPPLY CO., T/A KEYSTONE INDUSTRIES
  SUBSTANTIALLY EQUIVALENT 1
MYCONE DENTAL SUPPLY COMPANY, INC. (AKA KEYSTONE INDUSTRIES)
  SUBSTANTIALLY EQUIVALENT 1
MYERSON, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEW STETIC
  SUBSTANTIALLY EQUIVALENT 1
NUXEN S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
PAC-DENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PARK DENTAL RESEARCH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PERFLEX
  SUBSTANTIALLY EQUIVALENT 1
POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY
  SUBSTANTIALLY EQUIVALENT 1
PRISMATIK DENTALCRAFT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRO3DURE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
PROTECH PROFESSIONAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RECHERCHES TECHNIQUES DENTAIRES (R.T.D.)
  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
SUN MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SUN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYNCA MARKETING, INC.
  SUBSTANTIALLY EQUIVALENT 1
THE MYERSON COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
THERMOPLASTIC COMFORT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
TOKUYAMA DENTAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
UNIX-JAPAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VERTEX-DENTAL B.V.
  SUBSTANTIALLY EQUIVALENT 4
VERTEX-DENTAL BV
  SUBSTANTIALLY EQUIVALENT 2
VITA ZANHNFABRIK H. RAUTER GMBH CO.
  SUBSTANTIALLY EQUIVALENT 1
VOCO GMBH
  SUBSTANTIALLY EQUIVALENT 5
WHIP MIX CORP.
  SUBSTANTIALLY EQUIVALENT 1
WIELAND DENTAL + TECHNIK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
YAMAHACHI DENTAL MANUFACTURING CO.
  SUBSTANTIALLY EQUIVALENT 1
YAMAHACHI DENTAL MFG., CO.
  SUBSTANTIALLY EQUIVALENT 2
ZEST ANCHORS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIRKONZAHN SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 9 9
2015 8 8
2016 9 9
2017 2 2
2018 2 2
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 31 31
Patient-Device Incompatibility 18 18
Use of Device Problem 17 17
Improper or Incorrect Procedure or Method 14 14
Insufficient Information 6 6
Device Handling Problem 3 3
Product Quality Problem 3 3
Break 2 2
Device Operates Differently Than Expected 2 2
Inadequate Instructions for Healthcare Professional 2 2
Separation Failure 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Fracture 1 1
Gas Output Problem 1 1
Device Appears to Trigger Rejection 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 42 43
Burning Sensation 16 16
Rash 10 10
Reaction 10 10
Skin Inflammation/ Irritation 7 7
Local Reaction 6 6
Swelling 6 6
Complaint, Ill-Defined 6 6
Inflammation 6 6
Localized Skin Lesion 5 5
Insufficient Information 5 5
Pain 4 4
Peeling 3 3
Nausea 3 3
Dyspnea 3 3
Discomfort 3 3
Blister 2 2
No Code Available 2 2
Swelling/ Edema 2 2
Erythema 2 2
Eye Injury 2 2
Headache 2 2
Chest Pain 2 2
Itching Sensation 2 2
High Blood Pressure/ Hypertension 2 2
Unspecified Infection 1 1
Irritation 1 1
Dysphagia/ Odynophagia 1 1
Airway Obstruction 1 1
Anaphylactic Shock 1 1
Asthma 1 1
Toxicity 1 1
Injury 1 1
Ulcer 1 1
Swollen Lymph Nodes 1 1
Tachycardia 1 1
Ulceration 1 1
Vomiting 1 1
Sensitivity of Teeth 1 1
Chest Tightness/Pressure 1 1
Burn, Thermal 1 1
Chemical Exposure 1 1
Alteration In Body Temperature 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Unspecified Respiratory Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CMP Industries, Llc II Oct-30-2018
2 CMP Industries, Llc II Jun-29-2016
3 CMP Industries, Llc II Jun-29-2016
4 CMP Industries, Llc II Mar-09-2016
5 Envisiontec US Llc II Feb-15-2022
6 GRAPHENANO DENTAL SL II Feb-28-2024
7 Keystone Industries II Sep-12-2023
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