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510(k) Data Aggregation
K Number
K222707Device Name
IH Implant System
Manufacturer
Sewon Medix Inc.
Date Cleared
2023-07-07
(303 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Sewon Medix Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IH Implant System is device made of titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained restorations and terminal or interminal abutment support for fixed bridgework. IH Implant System is for stage surgical procedures. It is intended for delayed loading.
Device Description
IH Implant System is device made of titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained restorations and terminal or interminal abutment support for fixed bridgework. IH Implant System is for stage surgical procedures. It is intended for delayed loading. The system includes IH2 SLA Fixtures, IH Healing Abutments, IH Cement Abutments, and IH Multi-unit Abutments. The fixtures are endosseous threaded implants with a surface treatment of sand blasting and acid etching. The abutments are premanufactured and connect directly to the implant. The materials used are Pure Titanium Grade 4 (ASTMF67-06) and Titanium Alloy (ASTM F 136).
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K Number
K153521Device Name
IH Implant System
Manufacturer
Sewon Medix Inc.
Date Cleared
2016-10-14
(311 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Sewon Medix Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IH Implant System is device made of titanium and titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including ; cemented retained or screw retained restorations and terminal abutment support for fixed bridgework. IH Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
Device Description
IH2 SLA Fixture is dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SLA (Sandblasted, Large grit and Acid etched) treated. IH2 SLA Fixture has a various diameters 3.7 to 5.1 mm (3.7, 4.2, 4.6 and 5.1mm) and lengths 8.5 to 15mm (8.5, 10, 11.5, 13 and 15mm).
IH Prosthetic System is device made of titanium alloy, CCM alloy and POM intended for use as an aid in prosthetic restoration. It consists of Abutments (Healing Abutment, Solid Abutment, Cement Abutment, Angled Abutment, Temporary Abutment, Multi-unit Abutment and FreeMilling Abutment), Solid Protect Cap, Abutment Screws, Healing Cap, Cylinders (CCM Cylinder, Temporary Cylinder, Plastic Cylinder) and Cylinder Screws. Its surfaces are partially TiN coated or uncoated. IH Prosthetic System is supplied non-sterile and should be sterilized before use. It has a various diameters, gingival heights, heights and angles.
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