(39 days)
The NobelDirect™ OD Implant is a root form endosseous implant intended to provide immediate retention for removable tissue supported lower dentures in fully edentulous patients.
The NobelDirect™ OD Implant is a root form endosseous implant intended to provide immediate retention for a removable tissue supported overdenture. The NobelDirect™ OD Implant is intended for placement in the interforaminal area of the anterior mandible for the fully edentulous lower arch.
Nobel Biocare's NobelDirect™ OD Implant is a threaded one-piece root form endossions with an integrated ball attachment designed for one-stage surgical procedures and overdenture restorations. The integratou ball attablimont as intended to provide immediate retention for removable tissue supported lower overdentures in fully edentulous jaws.
Nobel Biocare's NobelDirect™ OD Implant can be placed in an edentulous arch or piaced simultaneously Nobel Diocare 3 Nobel Biocare's Nobel Biocare's NobelDirect™ OD Implant in immediate function applications, it is essential to obtain primary implant stability. Nobel Biocare's Gold Cap for Ball Attachment is to be utilized with the NobelDirect™ OD Implant.
Nobel Biocare's NobelDirect™ OD Implant is machined from titanium and is available with a straight or tapered contour. The NobelDirect™ OD Implant has a surface treatment that consists of a titanium oxide layer (TiUnite) that extends over the implant threads and onto the implant collar.
This 510(k) premarket notification is for a dental implant, the NobelDirect™ OD Implant. The provided document does not contain information regarding specific acceptance criteria, a study proving device performance against such criteria, sample sizes for test or training sets, ground truth establishment methods, or details about expert involvement. This type of information is typically found in performance testing sections of a 510(k) submission, which are not present in this excerpt.
The document primarily focuses on:
- Device Description: What the NobelDirect™ OD implant is (threaded one-piece root form endosseous implant with an integrated ball attachment).
- Intended Use: For one-stage surgical procedures and overdenture restorations, providing immediate retention for removable tissue-supported lower overdentures in fully edentulous jaws.
- Indications for Use: Specifically stated as "a root form endosseous implant intended to provide immediate retention for removable tissue supported lower dentures in fully edentulous patients." The "Indications for Use" form also specifies "immediate retention for a removable tissue supported overdenture. The NobelDirect™ OD implant is indicated for use in the interforaminal area of the anterior mandible for the fully edentulous lower arch."
- Substantial Equivalence: Listing legally marketed predicate devices (Brånemark System Implants K022562 and Replace One-Piece Implants K023952) to establish substantial equivalence.
- FDA Clearance Letter: Confirming that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and study details based on the provided text.
§ 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.