(29 days)
3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restoration and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures.
In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.
The PREVAIL implants are the same as the OSSEOTITE IOL implants [K031632] designed with an internal and external hex connection. The PREVAIL implants will have a lateralized seating surface on both the internal and external hex implants. The PREVAIL implants will be manufactured from Titanium Alloy per ASTM F-136 or Commercially Pure Titanium per ASTM F-67.
The PREVAIL implants will be available in lengths of 8.5mm to 15.0mm with a diameter of 3.4mm, 4.0mm, 5.0mm, and 6.0mm.
This appears to be a 510(k) premarket notification for a dental implant device, not a study evaluating device performance against acceptance criteria. The document describes a device modification and asserts substantial equivalence to previously cleared devices. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document because it is not a performance study report.
The document primarily focuses on regulatory approval based on equivalence to predicate devices, rather than clinical or technical performance testing beyond what is necessary to support the claim of equivalence.
§ 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.