(64 days)
The FRIALIT-2® EstheticBase Abutment is intended for use to fabricate screw-retained or cementable crowns and bridges.
The FRIALIT-2® EstheticBase Abutment is part of the FRIALIT-2® Dental Implant System. The EstheticBase Abutment is intended for the fabrication of screw-retained or cementable crowns and bridges. The EstheticBase Abutment is constructed of CP-2 titanium and is available in the same diameters as the FRIALIT-2® implant bodies. Each EstheticBase Abutment diameter is available with a 1, 2, 3, or 5mm gingival cuff height. The EstheticBase Abutment is available with a straight or angled configuration.
I apologize, but this document, a 510(k) premarket notification letter from the FDA, does not contain information about the acceptance criteria or a study proving device performance as requested.
The document is a clearance letter stating that the FRIALIT-2 EstheticBase Abutment is substantially equivalent to a legally marketed predicate device (Nobel BioCare TiAdapt Abutment System). It confirms that the device can be marketed subject to general controls and, if applicable, special controls or PMA requirements.
The "Summary of Safety and Effectiveness" section (Page 3-5) provides device identification, describes the device, identifies the predicate device, states the intended use, and discusses the technological characteristics. It asserts that the new device is "substantially equivalent" to the predicate in design, functionality, materials, and intended use. However, it does not detail any specific performance criteria, quantitative measures, or a study design and results showing that the device meets those criteria.
Therefore, I cannot provide the requested information from this document.
§ 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.