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510(k) Data Aggregation
K Number
K202046Device Name
LOTA SLA Dental Implant System and LOTA HA Dental Implant System
Manufacturer
KJ Meditech Co., Ltd.
Date Cleared
2022-03-01
(586 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
KJ Meditech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are indicated for use in partially or fully edentulous mandibles and maxillae, 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. The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
Device Description
The LOTA SLA Dental Implant system and LOTA HA Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy, which confirms to ASTM F136, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. All diameters are available with all lengths. The implants are used with the following abutments. The Shouldered Abutments and the Shouldered Hex Abutments have internal connection structure, and they adopt locking taper connection. They restore fixed crown and bridge restorations. The Shouldered Removal Abutment uses screw and locking taper connection to be connected with the fixture. It has the same intended use as the other abutments. All the abutments are not intended for angulation.
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K Number
K161923Device Name
J2A SLA Dental Implant System
Manufacturer
KJ Meditech Co., Ltd.
Date Cleared
2017-11-09
(484 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
KJ Meditech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The J2A SLA Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, 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. The J2A SLA Dental Implant System is for single and two stage surgical procedures. The system is intended for delayed loading.
Device Description
The J2A SLA Dental Implant System is internal hexagon type dental implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the system has been treated with SLA (sandblasted, Large- grit, Acid-etched).
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K Number
K151970Device Name
KJ Mini Implant System
Manufacturer
KJ MEDITECH CO., LTD.
Date Cleared
2016-10-21
(463 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
KJ MEDITECH CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KJ Mini Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. 2.0mm, 2.5mm, and 3.0mm diameter implants are intended to be used in central or lateral mandibular incisors. The KJ Mini Implant System is intended for single use only. It is for delayed loading.
Device Description
KJ Mini Implant System is a dental implant system made of Titanium 6AL 4V ELI Gt.23 alloy intended to be surgically placed in the bone of the upper or lower jaw arches. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the fixture part has been treated with R.B.M. The KJ Mini Implant System offers the following implants with various sizes.
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K Number
K140051Device Name
KJ EXTERNAL IMPLANT SYSTEM
Manufacturer
KJ MEDITECH CO., LTD.
Date Cleared
2014-10-30
(294 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
KJ MEDITECH CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KJ External Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. KJ External Implant System is for stage surgical procedures. It is intended for delayed loading.
Device Description
The KJ External Implant System is a dental implant system made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the implants has been treated with R.B.M (Resorbable Blast Media).
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K Number
K140052Device Name
J2I IMPLANT SYSTEM
Manufacturer
KJ MEDITECH CO., LTD.
Date Cleared
2014-10-30
(294 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
KJ MEDITECH CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
J2I Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or interminal or intermediate abuments upport for fixed bridgework. J21 Implant System is for single and two stage surgical procedures. It in intended for delating.
Device Description
The J2I Implant System is a dental implant system made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implant may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the system has been treated with R.B.M (Resorbable Blast Media).
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