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510(k) Data Aggregation
K Number
K240383Device Name
Highness Implant System
Manufacturer
Date Cleared
2024-10-31
(266 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
highness Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Highness Implant System is designed to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (crowns, bridges, and overdentures) in partially or fully edentulous individuals. It is used to the restore the patient's chewing function. Implants with diameter less than ø5.5mm are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated to the molar region and are indicated for delayed loading.
The Multi-Unit Abutments are intended for multi-unit restorations only and can be used up to 25 degrees when connecting cylinder.
Device Description
The Highness Implant System is a titanium-metal dental implant designed to be surgically placed in the bone of the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
The Highness Implant System consists of fixtures and abutments.
The fixture is made of pure titanium metal and is supplied sterile (gamma irradiated). The surface is SLA, sandblasted (using 425-180-micron MCD apatitic abrasive, which is a granular, multi-phase calcium phosphate composed primarily of hydroxyapatite and tricalcium phosphate), large grit, acid-etched (solution of hydrochloric acid and nitric acid), treated.
The abutments are made of Ti-6Al-4V ELI titanium alloy (ASTM F136). It consists of a Cemented Abutment, Angled Abutment, Solid Abutment, Temporary Abutment, and Multi-Unit Abutment Screw & Abutment Screw, which are intended for use as an aid in single- or multiple-unit prosthetic restorations, and the Multi-Unit Abutment and Multi-Angled Abutment, which are intended for use only as aids in multiple-unit prosthetic restorations. In addition, Cover Screws and Healing Abutments are prefabricated prosthetic components that connect directly to endosseous dental implants and are indicated as temporary components to allow for soft tissue healing. All abutments are supplied non-sterile and individually packaged in FDA cleared wraps and/or pouches. The abutments should be sterilized prior to use by the end-user. And temporary abutments are intended to be used 6 months.
The abutments are compatible with both HS - I and HS - VII implant bodies.
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