(90 days)
Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
Dynamic TiBase abutments are designed for retention of a CAD-CAM fabricated zirconia superstructure where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration. Dynamic TiBase abutments are provided in engaging and non-engaging designs for single-unit and multi-unit restorations, respectively. For each of the compatible OEM implant lines, the Dynamic TiBase abutments are provided with a gingival height (in the titanium base) ranging from 0.3 mm to 5 mm, and a prosthetic platform diameter ranging from 4.3 mm to 5.9 mm. Additional gingival height and angulation may be provided in the zirconia superstructure. All Dynamic TiBase abutments have a prosthetic post with a cut-out to accommodate a restoration with an angled channel for screw access when clinically necessary. The prosthetic post heights range from 3.8 mm to 4.5 mm (maximum height), and from 2.3 mm to 2.7 mm (cut-out height). Dynamic TiBase abutments with a 4.5 mm maximum post height may be shortened to no less than 4 mm for a single-unit restoration. All subject device abutments and abutment screws are made of titanium alloy (Ti-6A1-4V) conforming to ASTM F136 and ISO 5832-3. All zirconia copings (superstructures) for use with the subject device Dynamic TiBase will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.
The provided text is a 510(k) Summary for a medical device (Dynamic TiBase dental abutments). It describes the device, its intended use, and its substantial equivalence to previously cleared devices. However, it does not contain any information about acceptance criteria, the study design, or performance metrics typically associated with AI/ML-based medical devices.
The document explicitly states: "No clinical data were included in this submission." and focuses on non-clinical data to demonstrate substantial equivalence, primarily through:
- Mechanical testing: "mechanical testing conducted according to ISO 14801 to support the performance of the subject device abutments in conjunction with the compatible OEM implants."
- Reverse engineering analysis: "reverse engineering analysis (of OEM implants, OEM abutments, and OEM abutment screws) demonstrating compatibility between the subject device abutments and the OEM implants listed in the Indication for Use Statement."
- Material compatibility and sterilization: referencing previous 510(k) submissions for biocompatibility and sterilization validation.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance in the context of an AI/ML-based device (e.g., sample size, ground truth, expert adjudication, MRMC studies), as this information is not present in the provided text. The device described is a physical dental abutment, not an AI/ML diagnostic or assistive tool.
§ 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.)