(89 days)
TRATE Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. TRATE Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The TRATE Dental Implant System is an endosseous dental implant and abutment system consisting of screw-type implants manufactured of Titanium Alloy (Ti6AIV4. acc. to EN ISO 5832-3/ASTM F136). The implants are blasted with HAP / TCP for surface roughening, acid-etched and anodized. The cover screws, abutment fixation screws and abutments are made of Titanium Alloy (Ti6A14V). Some subject devices are surfaced anodized. TRATE Dental Implants are two-piece implants: TRATE Dental Implant System implant type is a two-component ROOTFORM implant with combined thread and tapered connection is intended for surgical placement in the upper or lower jaw to support crowns, bridges or overdentures in edentulous and partially edentulous jaws of patients in order to restore the patients chewing for single or multiple unit restorations. TRATE Dental Implant System implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Here's a breakdown of the acceptance criteria and study information for the TRATE Dental Implant System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like dental implants, "acceptance criteria" usually refer to performance specifications that the device must meet, often demonstrated through specific tests. The document mainly outlines a series of non-clinical tests rather than a statistical performance metric against clinical criteria.
| Acceptance Criteria (Test/Standard) | Reported Device Performance / Evaluation Method |
|---|---|
| Biocompatibility (ISO 10993) | Testing conducted to evaluate biocompatibility. (Implied: Meets ISO 10993 standards). |
| Bacterial Endotoxin Levels (ANSI/AAMI ST72) | Batch testing conducted on samples of water used in manufacturing (bimonthly) and from sterilized product (quarterly) to demonstrate levels |
§ 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.