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The BTI Interna Prosthetic Components are intended to function in the mandible or maxilla to support single and multiple-unit temporary or definitive restorations on the BTI Interna® Dental Implant System.

All digitally designed zirconia components for use with Aesthetic post abutments are to be sent to a BTI validated milling center for manufacture.

The purpose of this 510(k) is to expand the BTI product offering and include a variety of abutments compatible with the already cleared BTI Dental Implants. Subject device abutments include 15° Angled abutments, Transepithelial abutments, Temporary titanium abutments, Healing caps, Aesthetic post abutments and Screws. Aesthetic post abutments include Square abutments and Aesthetic interfaces for Transepithelials, as the bottom part of a two-piece abutment. A zirconia superstructure fabricated through CAD-CAM technology is the upper part of the two-piece abutment.

The subject 15º Angled Titanium abutments are designed to a BTI Interna Narrow implant, to hold single and multiple cement-retained restorations. The compatible BTI implants have been previously cleared in K211952. The abutments are offered with a 15º angulation and gingival heights of 3.0, 4.0, and 5.0 mm. They are manufactured in commercially pure titanium, with a TiN coating to enhance abutment aesthetic appearance.

The subject Temporary abutments are designed for single-unit screw-retained restorations on Transepithelial abutments are offered in prosthetic diameters of 3.5, 5.0 and 5.5 mm, with no angulation. They are manufactured from commercially pure titanium.

The subject Transepithelial abutments are designed for single-unit and multi-unit screw-retained restorations on previously cleared BTI implants. The compatible BTI implants have been previously cleared in K211952, K202825, K173257, and K151391. They are available in an engaging and a non-enqaging connection. They are offered in a prosthetic platform diameter of 3.5, 5.0 and 5.5 mm, and gingival heights ranging from 0.5 to 5.0 mm, with 0°, 17° and 30° angulation. They are manufactured from commercially pure titanium, with a TiN coating on abutment surface. The retention screw is provided with the abutment and is manufactured from titanium alloy with a DLC coating.

The subject Healing caps are designed to be connected to a Transepithelial abutment implant during the healing period, between Transepithelial placement and final dental restoration placement. These abutments are provided in prosthetic diameters of 3.5 and 5.0 mm. They are manufactured from commercially pure titanium and anodized.

The subject Aesthetic interfaces are two-piece abutments composed of a bottom half titanium component, and a patient-specific designed CAD-CAM zirconia superstructure as a top half component. The Aesthetic interfaces are to be attached to a Transepithelial abutment to hold single or multi-unit restorations. They are fabricated from commercially pure titanium, with a TiN coating to enhance abutment aesthetic appearance.

The design parameters for this top-half abutment fabrication are as follows:

• Minimum wall thickness: 0.4 mm -
• Minimum post height for single-unit restorations: 4.0 mm -
• Minimum gingival height: 0 mm in the zirconia superstructure -
• -Maximum gingival height: 6.0 mm
• -Maximum angulation: 0°

The subject Square abutments are two-piece abutments, composed of a bottom half titanium component, and a patient-specific designed CAD-CAM zirconia superstructure as a top half component. The Square abutments are to be attached to a BTI implant to hold single or multi-unit restorations. The compatible BTI implants have been previously cleared in K211952, K202825, K173257, and K151391. They are fabricated from commercially pure titanium, with a TiN coating to enhance abutment aesthetic appearance. The subject Square abutments are straight abutments (0%, and are provided in a variety of gingival heights ranging from 0.5 mm to 3.0 mm.

The design parameters for this top-half abutment fabrication are as follows:

• Minimum wall thickness: 0.4 mm -
• -Minimum post height for single-unit restorations: 4.0 mm
• Minimum qingival height: 0 mm in the zirconia superstructure -
• Maximum gingival height: 6.0 mm -

The zirconia superstructures for use with the subject Square abutments and Aesthetic Interfaces will be made at a BTI validated milling center and the material will conform to ISO 13356. The bonding cement recommended for the zirconia superstructure is Multilink Hybrid Abutment Cement (Ivoclar Vivadent AG), cleared in K130436.

The subject Screws are designed to attach Square abutments and Aesthetic Interfaces to the compatible BTI dental implant or Transepithelial abutment, respectively. The Screws are manufactured from titanium allov, with a DLC coating on screw thread. One subject Screw is also anodized for ease identification.

I am sorry, but the provided text does not contain the necessary information to describe the acceptance criteria and the study proving the device meets them, as it is a 510(k) summary for dental prosthetic components. This type of document focuses on demonstrating substantial equivalence to previously cleared devices rather than on performance studies with specific statistical acceptance criteria for a device involving AI or software.

The document discusses:

• Device Name: BTI Interna Prosthetic Components
• Regulatory Information: Class II device, product code NHA, regulation number 21 CFR 872.3630 (Endosseous Dental Implant Abutment).
• Indications for Use: To function in the mandible or maxilla to support single and multiple-unit temporary or definitive restorations on the BTI Interna® Dental Implant System. It also mentions that digitally designed zirconia components are to be sent to a BTI validated milling center for manufacture.
• Predicate Devices: Lists several predicate and reference devices, primarily other BTI Interna components and systems, and components from other manufacturers like AccelX Abutments and Medentika GmbH.
• Device Description: Detailed descriptions of various abutment types (15° Angled, Transepithelial, Temporary titanium, Healing caps, Aesthetic post abutments, and Screws), their materials (commercially pure titanium, zirconia), coatings (TiN, DLC), and design parameters (e.g., wall thickness, post height, gingival height, angulation).
• Performance Data (Non-clinical):
  • Moist heat sterilization validation.
  • Biocompatibility testing (ISO 10993-5 and ISO 10993-12).
  • Mechanical testing (ISO 14801).
  • Coating characterization.
  • Non-clinical worst-case MRI analysis.
  • Crucially, it explicitly states: "No clinical data were included in this submission."
• Technological Characteristics and Substantial Equivalence Discussion: A comparative analysis of the subject device with predicate and reference devices regarding indications for use, materials, surface treatment, restoration types, fixation methods, compatible implant platforms, dimensions (gingival height, angulation, prosthetic diameter), sterilization status, and packaging.

Why the requested information cannot be found in the provided text:

The request is for information typically found in the clinical study section of a submission for a device, especially those involving AI or software, where performance against a ground truth is evaluated. The provided document is a 510(k) summary for implant prosthetic components, which are mechanical devices, not AI/software. Therefore, concepts like "acceptance criteria" related to AI performance metrics (e.g., sensitivity, specificity), test set sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details are not applicable and not present in this document.

The "Performance Data" section in this document refers to non-clinical bench testing (sterilization, biocompatibility, mechanical strength, material characterization, and MRI compatibility) to demonstrate the physical and material properties of the dental components, and it explicitly states that no clinical data was included.

To answer your request, a different type of FDA submission document (e.g., one for an AI/ML-driven diagnostic or screening tool) would be required.

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