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510(k) Data Aggregation
K Number
K202963Device Name
ELEC Master, ELEC Master Dual
Manufacturer
Mgnewton Ltd.
Date Cleared
2023-05-05
(947 days)
Product Code
EIA, EBW
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
Mgnewton Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ELEC Master & ELEC Master Dual are intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment.
Device Description
This product consists of a micro motor controller and display panel. Receiving rated input of AC 24V, this device controls motor speed, and rotation direction through the motor control circuit inside the controller. Motor speed, light and rotation direction functions can be set on the display panel.
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K Number
K202965Device Name
CURA-Temp
Manufacturer
Mgnewton LTD.
Date Cleared
2022-12-21
(812 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
Mgnewton LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fabrication of temporary crowns, bridges, inlays and veneers. Fabrication of long-lasting temporary restorations. Lining material for prefabricated temporary crowns made of composite and metal.
Device Description
This product is ISO10477 Type 2 & Class 2, a light cured resin that forms the shape of a resin to make a temporary crown to protect the tooth for crown treatment for a certain period until the prosthesis is made. It is packaged in an impermeable syringe which is polymerized by light-cured energy and composed of base and photocatalytic agent.
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