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The Provata Implant System is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. The Provata Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

This submission includes threaded root-form dental implants with an internal hexagon interface and mating abutments. The implants are provided in two designs: Straight and Co-Axis (prosthetic platform inclined 12º from orthogonal to the implant). The Straight and Co-Axis implants are each provided in two diameters, 4.0 mm (actual major diameter 4.07 mm tapering to 2.6 mm), and 4.7 mm (actual major diameter 4.70 mm tapering to 3.13 mm), in one prosthetic diameter (3.575 mm), and in overall lengths of 8.5, 10, 11.5, 13, 15, 18 mm. The Co-Axis implants are to be used with straight abutments only.

This submission also includes: a Cover Screw (one design/size); Healing Abutments in three diameters (3.7, 4.5, and 5.5 mm) each in three gingival heights (3, 4, and 6 mm); Titanium Cylinder Abutments for temporary restorations in one size and two designs (engaging and non-engaging); Cosmetic Abutments in straight (0°), 12°, and 24° angled engaging designs for single-unit restorations; Passive Abutments with a plastic burn-out component, in one size and two designs (engaging); Compact Conical Abutments in straight (0°), 20°, and 30° angled designs for multi-unit restorations; and abutment screws.

All Provata implants are manufactured from unalloyed titanium conforming to ASTM F67, with a smooth machined collar. The remainder of the implant (the entire endosseous threaded surface) is grit-blasted. The subject device implant material and surface is identical to the implants cleared in K163634. The Cover Screw and all abutments (except Compact Conical) are manufactured from unalloyed titanium conforming to ASTM F67. The Compact Conical Abutments are manufactured from titanium alloy conforming to ASTM F136. The abutment screws are manufactured from titanium alloy conforming to ASTM F136, or gold-platinum alloy. All subject device components are manufactured in the same facilities using the same materials and manufacturing processes as used for the Southern Implants devices previously cleared in K163634 and K163060.

This 510(k) summary is for a dental implant system (Provata Implant System), not a software-driven AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria for an AI/ML device, its performance study details, or ground truth establishment.

Specifically:

• No Acceptance Criteria Table: The document describes the device's design, materials, and comparison to predicate devices, but does not present a table of acceptance criteria and performance metrics typically associated with AI/ML device validation (e.g., sensitivity, specificity, AUC).
• No AI/ML Performance Study: The "Performance Data" section states, "Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility... engineering analysis; dimensional analysis; sterilization validation... bacterial endotoxin... sterile barrier shelf life... and static and dynamic compression-bending according to ISO 14801. No clinical data were included in this submission." This explicitly indicates no clinical or reader study was performed for this device as it is physical hardware.
• No Ground Truth Establishment: Since no clinical data or AI/ML model performance is being evaluated, there is no mention of ground truth, expert opinions, or adjudication methods.

Therefore, I cannot provide a response with the requested information based on the provided text.

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