(62 days)
The intended use is to cut hard structures in the mouth, such as teeth or bone. One such application is to cut holes in cortical plate bone preparatory to creation of an osteotomy for placement of dental implants.
Dental burs are rotary cutting devices. Dental burs are shaped to provide a cutting action when simultaneously rotating and advanced forward into the target material with the application of pressure. Round Dental Burs are manufactured from carbide steel or tungsten carbide and may have friction grip or right anlge latch shanks.
This 510(k) submission for the Steri-Oss Round Dental Bur does not include any information about acceptance criteria or a study proving the device meets them, because it is a traditional medical device and not an AI/ML powered device.
Therefore, I cannot provide the requested information in the format of a table or answer the specific questions related to AI/ML device performance and validation.
The submission claims substantial equivalence to Brasseler Corporation's Round Dental Burs and relies on a comparison of design, material, and packaging characteristics, not performance data or AI/ML-related metrics. The document explicitly states "Performance Data: Not applicable."
§ 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.