(21 days)
P.004 NC Temporary Abutment is indicated for use in Straumann P.004 NC Bone Level implants for temporary restorations of single crowns and bridges for up to six months.
P.004 NC Healing Abutment, customizable is indicated for use in Straumann P.004 NC Bone Level implants to protect the inner configuration of the umplant and maintains, stabilizes and forms the soft tissue during the healing process for up to six months and should be placed out of occlusion.
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, permanent and temporary abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are temporary abutments.
The basal portion of the abutment has 4 grooves diametrically opposed that engage in the 4 protrusions of the P.004 implant. The abutment is 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 and directly veneered restorations. Healing abutments protect the inner configuration of the abutment and contours the soft tissue during the healing phase.
The provided document is a 510(k) summary for a dental abutment, specifically the "P.004 NC Temporary Abutments" and "P.004 NC Healing Abutment". It is an FDA submission for market clearance based on substantial equivalence to predicate devices, not a study report detailing performance against acceptance criteria in the way a clinical trial or AI validation study would.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not available in this document.
This document focuses on:
- Applicant and Device Identification: Contact information, device trade name, common name, classification, and regulation number.
- Predicate Device: Straumann P.004 Dental Implants (K062129) and P.004 RC Temporary Abutments (K070478) are named as legally marketed devices to which equivalence is claimed.
- Device Description: The P.004 Dental Implant System and the specific temporary and healing abutments are described.
- Intended Use: Detailed intended uses for the NC Temporary Abutment and Healing Abutments are provided.
- Technological Characteristics: A statement that the proposed abutments are substantially equivalent in material composition, basic design, and fundamental operating principles to currently marketed devices.
- FDA Communication: The letter from the FDA confirming substantial equivalence and market clearance.
- Indications for Use Statement: A formal statement of the device's indications for use.
In summary, this document does not contain the information required to fill out the requested table and answer the specific study-related questions. It is a regulatory filing, not a performance study report.
§ 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.)