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510(k) Data Aggregation
K Number
K222792Device Name
SNUCONE Tissue Level Implant System
Manufacturer
Snucone Co., Ltd.
Date Cleared
2023-06-08
(265 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Snucone Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SNUCONE Tissue Level Implant System is inticated 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 internediate Abutment support for fixed bridge work. Snucone implant system is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
Device Description
SNUCONE Implant System Fixture, also known as an endosseous implant, is surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis such as a crown, bridge, denture. Snucone's abutment and prosthetic components and tools are compatible with the Snucone's fixture only. The system includes Fixtures and Cover Screw, and Abutment and Component (Solid Abutment, InOcta Closing Screw, InOcta Healing Abutment, InOcta Abutment, InOcta Angled Abutment, InOcta Temporary Abutment, Platform Switching Abutment, and Abutment Screw).
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K Number
K210354Device Name
SNUCONE Bone Level Implant System
Manufacturer
SNUCONE Co., LTD.
Date Cleared
2022-07-13
(520 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SNUCONE Co., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SNUCONE Bone Level 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 bridge work. SNUCONE Bone Level Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
Device Description
SNUCONE Implant System Fixture, also known as an endosseous implant, is surgical component that interfaces with the bone of the jaw to support a dental prosthesis such as a crown, bridge, denture. Snucone's abutment and prosthetic components and tools are compatible with the Snucone's fixture only.
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