(86 days)
The BTI Interna Dental Implant System UnicCa® - 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 implants.
All digitally designed zirconia components for use with Square Aesthetic Abutments and Aesthetic Interfaces for Transepithelials are to be sent to a BTI validated milling center for manufacture.
The purpose of this submission is to obtain marketing clearance for the subject device abutments, Square Aesthetic Abutments and Aesthetic Interfaces for Transepithelials, as part of a two-piece abutment with a zirconia superstructure fabricated using CAD-CAM technology.
The subject Square Aesthetic abutments are stock manufactured abutments, to be attached directly to BTI dental implants with the Interna implant connection (Narrow, Universal Plus and Wide platforms), to hold single or multiple restorations. The Square Aesthetic abutments are compatible with BTI implants previously cleared in K211952, K202825, K173257, and K151391. The subject Square Aesthetic abutments are provided in a variety of gingival heights ranging from 0.5 mm, with a prosthetic platform diameter ranging from 4.0 mm to 5.9 mm, and a prosthetic post height of 3.5 mm. All versions include anti-rotation indexes to prevent crown or bridge rotation. Engaging and non-engaging designs are available for single and multiple restorations, respectively. The abutments are used with cemented and screw-retained restorations.
The design parameters for the CAD-CAM fabrication of the patient-specific superstructures for use with the Square Aesthetic Abutments are:
minimum wall thickness - 0.45 mm minimum post height for single-unit restoration - 4.2 mm maximum gingival height - 6.0 mm minimum gingival height - 0 mm in the zirconia superstructure maximum angle - 0°, straight only.
The subject Aesthetic Interfaces for Transepithelials are stock manufactured abutments, used to support single or multi-unit definitive prosthetic restorations over BTI Transepthelial Abutments (Unit and Multi-im, respectively). The compatible Transepithelial Abutments were previously cleared in K213106 and the Transepithelial Abutments are compatible with the BTI Interna connection implants (Narrow, Universal, Universal Plus and Wide platforms), previously cleared in K211952, K202825, K173257, and K151391. The previously cleared Transepithelial Abutments have a minimum gingival height of 1.0 mm and the Aesthetic Interfaces for Transepithelials have a minimum gingival height of 0.3 mm; when used together (as required) the minimum gingival height is 1.3 mm. The Aesthetic Interfaces for Transepithelials are provided in a range of prosthetic diameters from 3.5 mm, with a range of post heights from 3.5 mm. The Aesthetic Interfaces for Transepithelials are provided in two configurations, Straight and Expanded configurations have a larger prosthetic platform diameter than the Straight configurations with the same platform diameter. Overall, the prosthetic platform diameters range from 3.5 mm to 6.5 mm.
The design parameters for the CAD-CAM fabrication of the patient-specific superstructures for use with the Aesthetic Interfaces for Transepithelials vary for the minimum wall thickness and prostheight depending on the design of the Aesthetic Interface and the corresponding Transepithelial Abutments. The overall design parameters for the CAD-CAM fabrication of the patient-specific superstructures for use with the Aesthetic Interfaces for Transepithelials are:
minimum wall thickness - 0.4 mm minimum post height for single-unit restoration - 4 mm maximum gingival height - 6.0 mm minimum gingival height - 0 mm in the zirconia superstructure maximum angle - 0°, straight only.
All zirconia superstructures for use with the subject device will be made at a B.T.I. Biotechnology Institute, S.L. validated milling center under FDA quality system regulations, and the material will conform to ISO 13356. All superstructures will be bonded to the abutment using Multilink Hybrid Abutment Cement (Ivoclar AG, cleared in K130436).
All subject device components are manufactured from unalloyed titanium conforming to ASTM F67 and ISO 5832-2 and are provided with a Titanium Nitride (TiN) coating to enhance of the device. All subject device components are used with abutment and prosthetic screws previously cleared in K213106, and K053355.
The provided text is a 510(k) summary for the BTI Dental Implant System UnicCa® - Aesthetic Post Abutments. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, manufacturing, and intended use, rather than presenting a performance study with acceptance criteria for an AI/ML powered device.
Therefore, the requested information regarding acceptance criteria, study details (sample sizes, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance), and ground truth establishment for a device performance study cannot be extracted from this document, as it describes a dental implant abutment, not a device whose performance is measured through such clinical or AI-centric metrics.
The document states: "No clinical data were included in this submission." This explicitly indicates that the type of study typically associated with performance criteria, and the establishment of ground truth for AI/ML models, was not part of this 510(k) submission.
The "Performance Data" section solely discusses non-clinical data related to:
- MRI review for components.
- Moist heat sterilization for non-sterile devices.
- Biocompatibility testing (cytotoxicity) for the final abutment.
These are standard engineering and material science performance tests for medical devices, not an evaluation of a diagnostic or therapeutic AI/ML device's accuracy or effectiveness in a clinical context.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)