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510(k) Data Aggregation
K Number
K211978Device Name
Jplant
Manufacturer
Date Cleared
2022-01-05
(194 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
JJ Medical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Jplant is intended for use in partially or fully edentulous maxilla, in support of single of multiple-unit restorations including cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Jplant is for single stage surgical procedures. This system is intended for delayed loading.
Jplant is intended for use in partially or fully edentulous mandibles and maxilla, in support of single or multiple-unit restorations including cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Jplant is for single stage and two stage surgical procedures. This system is intended for delayed loading.
Device Description
The Jplant is dental implant which is made of titanium alloy intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices such as artificial teeth, and to restore the patients chewing function. The fixture has the following sizes.
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