Search Results

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 cement and screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

This device is compatible with the following manufacturers' implant systems: Nobel Replace® Straight Groovy 3.5mm, Nobel Replace® Select Tapered and Straight 3.5mm and NobelSpeedyTM 3.5mm implants.

Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. Zirconia may have a variation in shade. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments in Zirconia for Nobel Replace Implants and abutment screws are made from biocompatible yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6872 & 13356 and may be produced in any composition complying with the values specified by these standards.. The abutment screws are made from titanium grade Ti-6A1-V ELI and meets ASTM Standard F-136. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with Nobel Replace® Straight Groovy 3.5mm. Nobel Replace® Select Tapered and Straight 3.5mm, and NobelSpeedy™ 3.5mm implants.

The provided document is a 510(k) summary for a dental abutment, not a study report for an AI/ML device. Therefore, it does not contain information on acceptance criteria, reported device performance, study types (e.g., MRMC, standalone), ground truth establishment, or sample sizes related to AI/ML device development and evaluation.

The document discusses the substantial equivalence of the "Atlantis™ Abutment in Zirconia for Nobel Replace Implant" to predicate devices based on intended use, material, design, and performance, typical for a traditional medical device submission.

As a result, I cannot populate the requested table and answer the study-related questions from the provided text. The questions are designed for AI/ML device evaluation studies, which are not detailed in this 510(k) submission.

Ask a specific question about this device