(92 days)
The Atlantis™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Atlantis™ Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration. in partially or completely edentulous patients. The abutment screw is intended to secure the crown abutment to the endosseous implant.
Atlantis™ Straumann Bone Level Abutment in Zirconia is compatible with the Ø3.3 mm Straumann Bone Level Implant.
Atlantis Straumann Bone Level Abutment is a patient specific dental implant abutment for screw-retained, cement-retained or friction fit restorations. Atlantis Straumann Bone Level Abutment is provided in one diameter (03.3 mm) and two designs: Atlantis Straumann Bone Level Abutment and Atlantis Straumann Bone Level Crown Abutment. The coronal portion of Atlantis Abutment is fabricated as a patient specific abutment for prosthesis attachment. The coronal portion of Atlantis Crown Abutment is fabricated as a single tooth final restoration and is shaped in the design of the final prosthesis onto which porcelain is added. Both designs are compatible with the Straumann Bone Level implant Ø3.3 mm. Atlantis abutments are made from yttria-stabilized zirconia (Y-TZP) conforming to ISO 13356 Implants for surgery-ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and are used with a titanium alloy abutment screw.
The provided text is a 510(k) summary for the Atlantis™ Straumann Bone Level Abutment, which is a dental implant abutment. This document does not describe a study involving acceptance criteria related to software performance, AI algorithms, or human reader effectiveness. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing for a physical medical device.
Therefore, the requested information cannot be extracted from the provided text as it does not contain details about:
- Acceptance criteria for a software/AI device.
- A study proving a device meets such acceptance criteria.
- Sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for AI/software development.
The "studies" mentioned in the document are:
- Non-clinical testing data: engineering analysis, dimensional analysis.
- Static and dynamic compression-bending testing: according to ISO 14801 Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants.
These tests are designed to demonstrate the physical performance and safety of the dental abutment, ensuring it meets established engineering standards for medical devices of its type, rather than evaluating interpretive or diagnostic capabilities of an algorithm.
§ 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.)