(135 days)
The Atlantis Abutment is intended for use as an accessory to 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 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 Biocare, Zimmer Dental, 3i, Lifecore, Sterngold, Innova and BioHorizons.
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.
Also, 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. The subject abutments are indicated for cemented restorations.
The Atlantis™ Abutments in Zirconia for Nobel Replace is made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) and meets ISO Standards 6972 & 13356). The abutment screw is 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® Select Straight, Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage for the 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) Implants.
The provided text describes a 510(k) premarket notification for a dental implant abutment and does not contain information about acceptance criteria, device performance metrics, or study results in the context of AI/ML-based medical devices. The document focuses on establishing substantial equivalence to predicate devices based on intended use, materials, design, and performance, rather than presenting a performance study against predefined acceptance criteria.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text. This document is a regulatory submission for a physical medical device, not a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool, which typically would involve such performance study details.
§ 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.)