(98 days)
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges or overdentures.
The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are abutments.
Abutments can have an engaging or non-engaging connection to the implant. The basal portion of the engaging abutment has 4 protrusions diametrically opposed that engage in the 4 grooves of the P.004 implant. Non-engaging abutments do not lock into the implant via the protrusion/groove connection. Both abutments are seated in the implant with a screw which is mounted in the basal portion of the abutment. The abutment is used for cemented and screw-retained restorations.
This is a 510(k) premarket notification for a dental abutment, not a study describing the acceptance criteria and performance of an AI/ML powered medical device.
Therefore, I cannot extract the information requested as it is not present in the provided document. The document describes a traditional medical device (dental abutment) and its substantial equivalence to previously marketed devices based on material composition, basic design, and intended use, not on performance metrics derived from a study comparing an algorithm's output to ground truth.
Specifically, the document contains:
- Applicant and Device Information: Name, address, device trade and common names, classification.
- Predicate Device: K062129 synOcta® Gold Abutment, K041295.
- Device Description: What the P.004 dental implant system is, and its components (implants, abutments, surgical/prosthetic parts). It describes the abutment's connection types (engaging/non-engaging) and its seating mechanism with a screw.
- Intended Use: Placed into dental implants to support prosthetic reconstructions (crowns, bridges, overdentures).
- Technological Characteristics: States substantial equivalence to marketed devices in intended use, material, design, and operating principles.
- FDA Clearance Letter: Confirms substantial equivalence and market clearance.
- Indications for Use Statement: Reiterates the intended use and specifies prescription use.
None of this information pertains to an AI/ML device study or its associated performance metrics, ground truth, sample sizes, or expert adjudication methods.
§ 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.)