(88 days)
- For implantation into any area of the fully edentulous maxilla and mandible for the support of a removable or fixed dental prosthesis
- For implantation into any area of the partially edentulous maxilla and mandible for the support of a removable or fixed dental prosthesis
- For single tooth or multiple unit prosthesis
- For single stage or two stage surgical procedure
- For immediate placement and immediate function when multiple units are splinted and for single units when adequate initial stability is achieved in type I or type II bone and under appropriate occlusal loading. Multiple units may be splinted with a bar. In edentulous cases restored with a fixed prosthesis, four or more implants must be used.
- Abutments are intended for use in conjunction with compatible Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restoration.
The modification of the Blue Sky Bio Dental Implant System consists of angled abutments and abutments to be custom milled to a specific angle to allow restoration of implants which are placed at an off-axis. A line of UCLA type straight abutments is introduced. In addition, an implant with a length of 8mm is introduced. A ceramic surgical osteotomy drill is also introduced.
The provided text is a 510(k) summary for the Blue Sky Bio Dental Implant System. It describes the device, its indications for use, and the regulatory approval process. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
This document is a regulatory submission for a medical device that outlines its description and intended use, and confirms its substantial equivalence to a predicate device. It is a design and manufacturing document, not a performance study report.
Therefore, I cannot populate the table or answer the other questions based on the provided text because the required information is not present.
§ 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.