(92 days)
The Straumann NC Temporary Abutments are intended for use with the Straumann Dental Implant for temporary restoration of single crowns and bridges.
The Straumann NC Temporary Abutments are indicated for use in Straumann NC Bone Level Implants for temporary restorations of single crowns and bridges for up to six months.
The Straumann 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.
Abutments are placed on dental implants to provide support for dental restorations. Temporary abutments act as a basis for the fabrication of individual temporary restorations and temporary bridges on Straumann Dental Implants.
This is a medical device application for the Straumann NC Temporary Abutments. This submission focuses on establishing substantial equivalence to a predicate device rather than conducting a de novo study with acceptance criteria and performance evaluation against those criteria. Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text.
Here's why and what the text does provide:
- 510(k) Submissions: These submissions primarily aim to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics, intended use, and materials. It typically does not involve setting specific performance acceptance criteria for the new device as would be seen in a clinical trial designed to prove effectiveness or safety against predefined benchmarks.
The document states:
- "The proposed temporary abutments are substantially equivalent to the currently marketed devices. The intended use is identical to the predicate devices. The proposed abutment has the same material composition, basic design and fundamental operating principles to the currently marketed devices."
Therefore, I cannot populate the table or answer the specific questions you posed because the provided text does not contain the type of study data and acceptance criteria you are looking for. The focus of this document is on regulatory equivalence, not on a detailed performance study against a set of predefined acceptance criteria for a new device.
§ 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.)