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TPLC
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show TPLC since
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2024
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Device
resin, denture, relining, repairing, rebasing
Product Code
EBI
Regulation Number
872.3760
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
1. K200580
FotoDent denture
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
2
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
2
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
2024
1
1
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
35
36
Burning Sensation
10
10
Rash
9
9
Skin Inflammation/ Irritation
8
8
Local Reaction
6
6
Localized Skin Lesion
5
5
Insufficient Information
5
5
Swelling
3
3
Discomfort
3
3
Peeling
3
3
Reaction
3
3
Swelling/ Edema
3
3
High Blood Pressure/ Hypertension
2
2
Nausea
2
2
Itching Sensation
2
2
Blister
2
2
Chest Pain
2
2
Dyspnea
2
2
Headache
2
2
Unspecified Infection
1
1
No Code Available
1
1
Inflammation
1
1
Asthma
1
1
Burn, Thermal
1
1
Chemical Exposure
1
1
Injury
1
1
Erythema
1
1
Pain
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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