(69 days)
The SICace System Dental Implant is a root form endosseous dental implant system that is indicated to be implanted in the upper and/or lower jaw arches. The implants may be used in combination with various SICace System Abutments for single or multiple unit prosthetic attachment to restore a patient's chewing function.
Patient's must be applicable for dental treatment with endosseous implants.
In cases where the ridge is too narrow to receive a 4.0 mm or a 5.0 mm diameter implant, the 3.4 mm implant can be used. Because of reduced strength due to the small diameter, these implants should be rigidly joined to other implants and used only where loads are not extreme.
The SICace System Abutment is intended to be placed into the SICace System Implant to provide a safe and effective fit of screw retained and/or cementable crowns and bridges.
SICace dental implant system is a root-form endosseous dental implant device made out of grade 4 titanium according ASTM F 67. The implants are available in three different diameters (ø3.4 mm, ø4.0 mm, ø5.0 mm) and various lengths from 9.5 mm. The anchorage surface is grit blasted and acid etched for faster osseointegration and secondary stability.
Equal to the predicate device SICpro dental implant, the face side of the SICace dental implant has a hexagon drill hole and a standard screw thread to ensure and anti-rotational connection of the congruent abutment and the implant. Throughout the different diameters the hexagon drill hole has identical measurements.
SICace dental implants are delivered single packed in combination with an implant cover screw and supplied in sterile condition (sterilized by gamma-radiation).
SIC angled abutments are various in lengths and diameters and made out of titanium ASTM F 136. Through a hexagon socket and a vertical drill hole, the abutments can be connected with the implant secure and anti-rotational.
SIC angled abutments are supplied in non sterile condition. These parts of the system can be sterilized by the user by using a standardized and validated sterilization process.
The provided text does not contain information about acceptance criteria for device performance, a study to prove meeting acceptance criteria, or any of the detailed study parameters (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).
The document is a 510(k) summary for the SICace Dental Implant System, focusing on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study data against specified acceptance criteria. It describes the device, its classification, predicate devices, and indications for use, ultimately concluding that it is substantially equivalent.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.