(338 days)
The Hex-Lock Temporary Abutment is designated for use on the internal hexagon implant interface for less than twenty-eight days usage which is placed in the edentulous mandibles or maxillae, for fixation of a final crown. The intended use of the Hex-Lock Temporary Abutment is identical to the intended use of the predicate device, the ProTect abutment from Friadent. The plastic temporary abutment is intended to be used to create an esthetic emergence through the gingiva between implant uncovering and final restoration with screw-retained or cemented restorations. Use of the plastic abutment is not to exceed twenty-eight (28) days. If time between placement of temporary abutment and final restoration needs to exceed twenty-eight (28) days then the use of a titanium abutment, which is indicated for longer-term use, is required.
The abutment can be used for either a single tooth or multiple tooth unit provisional restoration and can be modified in height to suit individual needs during the fabrication of the provisional prosthesis.
The plastic temporary abutment can be used to create esthetic, screw-retained or cemented provisional restorations at second stage uncovering. Once the restoration has been applied to the temporary abutment, it can be used to develop a more esthetic emergence profile. Temporary abutment is not to be used as a permanent abutment. Not to exceed 28-days of placement.
The Hex-Lock Temporary Abutment is available in 4.5mm, 5.5mm, and 6.5mm outer diameter lengths for the internal hexagon interface. The abutment/implant platform diameter is 3.5mm, 4.5mm, and 5.7mm for the internal hexagon interface. All the abutments exhibit the internal hexagon interface.
The Hex-Lock Temporary Abutment is a new abutment design that is being submitted to interact with an internal hexagon dental implant system. The abutment features an internal hex engaging plastic cylinder with retentive parallel walls and a flared cuff used for short term restorations less than twenty-eight (28) days. This abutment will attach directly to the implant with a retaining screw with a long shaft that protrudes from the top of the abutment to facilitate the fabrication of the provisional prosthesis. Both screws allow for length reduction for custom height restorations. The abutment will exhibit the internal hex engaging feature. The abutment/implant interface remains unchanged.
The provided text is a 510(k) summary for a dental device (Hex-Lock Temporary Abutment). It focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use. There is no information within the document about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics or clinical outcomes.
Therefore, I cannot provide the requested information. The document does not describe any such studies, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This type of submission relies on demonstrating equivalence rather than fulfilling performance criteria through a specific study as would be seen for devices requiring clinical performance data.
§ 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.