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510(k) Data Aggregation
K Number
K160850Device Name
Nucleoss Tpure Implant System
Manufacturer
SANLILAR TIBBI CIHAZLAR MED. KIM.SAN.TIC.LTD.STI
Date Cleared
2017-08-04
(494 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
SANLILAR TIBBI CIHAZLAR MED. KIM.SAN.TIC.LTD.STI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nucleoss Tpure Implant System are medical devices 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 Tpure Dental Implants are intended for delayed loading after 12 weeks.
Nucleoss Abutments and Prosthetic parts are intended for use with Nucleoss Tpure Dental Implants in the maxillary and/ or mandibular arches to provide support for crowns, bridges or overdenture for edentulous patients.
Device Description
The Nucleoss Tpure Implant System consists of the Nucleoss Tpure Dental Implant, Nucleoss Dental Abutments, Covers, Gingiva Formers, Comfort Caps, and accessories.
The Nucleoss Tpure Implant is a bone level, root form implant constructed of unalloyed titanium per ISO 5832-2, with an SLA surface treatment. Nucleoss Tpure Implants have a conical form design, with a double lead thread form and two vertical anti-rotation grooves. The internal structure is designed as a conical internal hex connection with 80 degree bevel.
Nucleoss Tpure Implants are provided in the following sizes: 3.4 mm diameter with lengths of 10, 12 and 14 mm, and 3.8, 4.2, 5.0 mm diameters with lengths of 8, 10, 12, and 14 mm.
Nucleoss Dental Abutments are constructed of titanium alloy per ISO 5832-3and are intended for cement-retained and screw-retained restorations. An internal hexagon allows connection to the Nucleoss Tpure implant. Nucleoss Dental Abutments are available in Straight, Angled, Multi-unit, Ball and Equator designs. The Angled abutment is provided in angles of 10, 20 and 30 degrees. The Multi-unit abutment is available in a straight design, and angled designs of 17 and 30 degrees. Nucleoss Covers, Comfort Cap and Gingiva Formers are available for use during the healing period following surgical placement of the implant. The Nucleoss Tpure Implant System also includes metal housings combined with caps to provide a secure coupling for the denture prosthetic attachment to the Ball and Equator abutments.
All of the Nucleoss Tpure Implant System components are single-use devices. The Nucleoss Tpure Implant and related Cover is provided sterile. The Nucleoss Abutments and accessories are provided nonsterile for end-user sterilization.
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