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510(k) Data Aggregation
K Number
K192062Device Name
Nucleoss T6 Dental Implant System
Date Cleared
2020-08-27
(392 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. St
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Nucleoss T6 Dental Implants are intended to be surgically placed in the bone of the maxillary and/or mandibular arches to provide support for prosthetic restorations (crowns, bridges or overdenture) in edentulous or partially edentulous patients to restore a patients' chewing function. Nucleoss T6 Dental Implants are intended for delayed loading after 12 weeks.
Nucleoss Abutments and Prosthetic parts are intended for use with Nucleoss T6 Dental Implants in the maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures for edentulous or partially edentulous patients.
Device Description
The Nucleoss T6 Dental Implant is a bone level implant constructed of unalloyed titanium (ISO 5832-2). The surface of the T6 implant is a sand-blast and acid-etch (SLA) surface treatment.
T6 Implants: Nucleoss T6 implants have a cylindrical form design, with a double lead thread form and two helical anti-rotation grooves. The thread structure is a reverse buttress. The internal structure is designed as a conical internal hex connection with 140 degrees.
The Nucleoss Dental Abutments are intended for use with the Nucleoss T6 Dental Implants in the maxillary and/or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.
Abutments: The Nucleoss Dental Abutments consist of the following designs: Standard Straight, Esthetic Straight, Esthetic Angled, Ball and Equator, Cover, Gingiva Former and Screw. Nucleoss Dental Abutments are cement-retained and screw-retained restorations and intended for placement on Nucleoss T6 implants with diameters of 3.5, 4.1 and 4.8 mm. The connection to the dental implant is achieved by an internal hexagon. These devices are constructed of titanium alloy (Ti6Al4V ELI) per ISO 5832-3.
Covers and Gingiva Formers: The Nucleoss Cover and Gingiva Former are used during the healing and prosthesis period following surgical placement of the dental implant. All of these devices are constructed of titanium alloy (Ti6Al4V ELI) per ISO 5832-3.
Screws: The Nucleoss Dental Implant and Abutments devices also include screws for securing abutments to the implant to provide a secure coupling for the denture prosthetic attachment to the abutment.
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