(219 days)
The Implanova® implants are intended for endosseous implantation in the mandible and maxilla for use as an artificial root structure. These root form implants can be used to replace single or multiple missing teeth and/or to support a fixed or removable prosthesis in partially or completely edentulous upper and lower dental arches in the Implanova® system including implant fixtures, abutments, healing caps, cover screws, and retention screws are intended for use by prescription only. Implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Short implants (6mm) are intended for delayed loading.
All 3.0mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws.
All 3.0mm implants must be splinted if two or more are used adjacent to each other. The 3.0mm implants (except 8mm length) are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading, The 3.0mm implant with 8mm length is intended for delayed loading.
Implanova® All-in-One™ implants are indicated to be used when primary stability of the implant allows presence of an abutment at the time of placement. Implanova® All-in-One™ are immediately loaded by the presence of the abutment, but the occlusal forces need to be controlled and restricted while osseointergration takes place.
All Implanova® Bone Level implant fixtures are compatible with the straight type restorative components listed in the table below, including straight type abutment screws and straight type temporary abutments that are intended to be on Astra Tech's OsseoSpeed™ TX 3.5S and OsseoSpeed™ TX 4.0S implant fixtures.
The Implanova® TiTACH™ system is indicated as a removable attachment of a full arch prosthesis when used in pairs and for a partial arch prosthesis in pairs. Minimum of two attachments are indicated to secure a complete or partial denture on 2-6 implants. This prosthesis is removable by patients.
The Implanova® FRIDGE® is indicated as a fixed attachment of a full arch prosthesis when used with 6 implants. This prosthesis is fixed for patients and removable by dentists.
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I am sorry, but the provided text does not contain information about studies, acceptance criteria, or the performance of the "Implanova" device. The document is an FDA 510(k) clearance letter and its associated "Indications for Use" statement, primarily focusing on the regulatory approval and intended uses of the dental implants and related components.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.
§ 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.