Search Results
Found 1 results
510(k) Data Aggregation
K Number
K153650Device Name
Microdent Ektos Implant System
Manufacturer
Date Cleared
2016-05-20
(151 days)
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
IMPLANTS MICRODENT SYSTEM S.L
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Microdent Ektos Implant System is indicated for surgical placement in the upper or lower jaw arches, for single-stage or two-stage surgical procedures and cemented, screw retained restorations or overdentures. Microdent Ektos Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Small diameter implants are indicated only for replacement of central and lateral incisors in the maxilla and mandible.
Device Description
Microdent Ektos Implant System is comprised of dental implants and prosthetic components. Microdent Ektos dental implants are internal connection endosseous implants machined in titanium that can be used with deferred load or immediate load techniques. The implant is designed to be inserted at crestal level. Microdent Ektos Implant is recommended to be placed at crestal bone level. The implant has an internal hexagonal connection. Microdent Ektos Implants are provided with blasted surface. The implants are supplied sterile and the abutments are provided non-sterile. The system also contains Microdent Ektos abutments made of Ti-6AL 4-V-ELI alloy. The abutments Conical, Multi-function (supplied with the implant) and Mini Capitel are used for cemented and screw-retained restorations. The following Cover Screws are provided to protect the inner configuration of the implant and are supplied sterile with the implant. Healing abutment to shape the soft tissue during the healing phase. The Retention Screws are used for securing the abutments to the implant. Overdenture retention consists of a titanium alloy socket that attached to a threaded post for use with titanium endosseous implants having an internal threaded socket. Both devices have a plastic component that has a shape on one and that mate into the titanium socket, while the other end with metal cap is attached to the denture.
Ask a Question
Ask a specific question about this device
Page 1 of 1