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510(k) Data Aggregation
K Number
K200193Device Name
Kisses Plus Implant System
Manufacturer
ACHIMHAI Medical Corporation
Date Cleared
2021-08-06
(557 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
ACHIMHAI Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kisses Plus Implant System is indicated for use in partially or fully edentulous mandibles and maxilla, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
The Kisses Plus Implant System is for single and two stage surgical procedures. It is for delayed loading.
Device Description
This 510k is to add the following abutments to Kisses Plus Implant System: Multi Straight Abutment, Multi Angled Abutment, CCM Abutment, and Multi CCM Abutment. The description includes details on the material composition (Ti 6A14V ELI or Co Cr Mo) and dimension ranges for each abutment type. It also mentions the abutment screws used with these abutments.
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K Number
K172630Device Name
Kisses Plus Implant System
Manufacturer
ACHIMHAI Medical Corporation
Date Cleared
2018-04-03
(214 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
ACHIMHAI Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kisses Plus Implant System is indicated 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.
The Kisses Plus Implant System is for single and two stage surgical procedures. It is for delayed loading.
Device Description
Kisses Plus Implant System offers three different types of implants: Double Hex, and Kisses Single Hex. The Double Hex type has the doubled hex part to be coupled to the superstructure, whereas, the Single Hex type and Kisses Single Hex type has single hex part.
The Double Hex type fixture is a substructure of a dental implant system. It consists of the hex part to be coupled to the superstructure, the macro thread part to be fixed to the bone, and the cutting edge part with the self-tapping function. It offers double hex type.
The Single Hex type fixture is a substructure of a dental implant system. It consists of the hex part to be coupled to the superstructure, the macro thread part to be fixed to the bone, and the cutting edge part with the self-tapping function. It offers single hex type.
The Kisses Single Hex type fixture is a substructure of a dental implant system. It consists of the hex part to be coupled to the superstructure, the macro thread part to be fixed to the bone, and the cutting edge part with the self-tapping function. It offers single hex type.
Kisses Plus Implant System also includes the following components: Angled abutment, Duplex Abutment, Duplex Milling Abutment, Simplex Abutment, Temporary Abutment, Solid Screw Abutment, Ball Abutment, Ball Cap, Cover Screw, Healing Abutment.
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K Number
K170394Device Name
Kisses Mini
Manufacturer
ACHIMHAI Medical Corporation
Date Cleared
2017-10-06
(240 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
ACHIMHAI Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kisses Mini is indicated for use in partially or fully edentulous maxilla, in support of single or multiple-unt restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Kisses Mini is for single and two stage surgical procedures. It is for delayed loading.
The intended use of the 3.2 mm Internal Hex fixtures is limited to the replacement of maxillary lateral incisors.
The intended use of the single-piece post type fixture to replacement of mandibular central and lateral incisors.
The ball-type single-piece implant is intended for stabilization and retention of overdentures.
Device Description
KJ Mini offers three different types of implants: 2-Piece Type, Post Type, and Ball Type.
The 2-piece type fixture is a substructure of a dental implant system to replace a single tooth, and the lost root of edentulous patients. It consists of the hex part to be coupled to the superstructure, the single thread part to be fixed to the bone, and the cutting edge part with the self-tapping function. It offers single hex type and double hex type.
The post type fixture is a substructure of a dental implant system to replace a single tooth, and the lost root of edentulous patients.
The ball type fixture is a substructure of a dental implant system to replace a single tooth, and the lost root of edentulous patients.
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