(114 days)
The Dentis Dental Implant system is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants.
The Dentis Dental Implant System is comprised of dental implants, surgical instruments and prosthetic components. The system is designed for conventional two-stage for single and multiple unit prosthetics. The Dentis Dental Implant System consists of machined titanium, screw-form dental implant Ø 3.5mm. Ø 3.7mm, Ø 4.1mm, Ø 4.3mm, Ø 4.8mm, Ø 5.5mm, 6.0mm in diameter. They are available in length of 7-14 mm. The implant's raw material is titanium and its alloys for surgical implant applications (as per ASTM-F-67, ASTM-F-136). Surfaces include as machined surfaces, grit blasted and surfaces treated with Resorbable Blast Media (RBM) roughened surface. The System includes surgical instruments such as twist drill, bone tap, Trephine
The provided text describes the Dentis Dental Implant System and its 510(k) submission, confirming its substantial equivalence to predicate devices. However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets acceptance criteria, device performance metrics, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, or any details about MRMC or standalone studies.
The "Performance" section explicitly states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This indicates that performance testing was done, but the details of these tests, including the criteria and results, are not provided in this summary.
Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance or answer the other specific questions about the study design, ground truth, or expert involvement based on the provided text alone. The document focuses on regulatory equivalence and device description rather than detailed clinical or performance study results.
§ 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.