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TPLC
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show TPLC since
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Device
coating, filling material, resin
Product Code
EBD
Regulation Number
872.3310
Device Class
2
Premarket Reviews
Manufacturer
Decision
BELPORT COMPANY, INC., GINGI-PAK
SUBSTANTIALLY EQUIVALENT
1
DREVE DENTAMID GMBH
SUBSTANTIALLY EQUIVALENT
1
ENAMELITE LLC
SUBSTANTIALLY EQUIVALENT
1
GC AMERICA INC.
SUBSTANTIALLY EQUIVALENT
1
INNOVATION MEDITECH GMBH
SUBSTANTIALLY EQUIVALENT
1
SHOFU DENTAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
VITA ZAHNFABRIK GMBH H RAUTER & CO
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
1
1
2021
1
1
2023
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Use of Device Problem
2
2
Patient-Device Incompatibility
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Improper Chemical Reaction
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Hypersensitivity/Allergic reaction
6
6
Dyspnea
5
5
Swelling/ Edema
5
5
Nausea
1
1
Pain
1
1
Vertigo
1
1
Dizziness
1
1
Inadequate Pain Relief
1
1
Abdominal Distention
1
1
Unspecified Respiratory Problem
1
1
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