P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS

• K Number: K081005
• Device Name: P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS
• Manufacturer: INSTITUT STRAUMANN AG
• Date Cleared: 2008-05-02 ( 24 days)
• Product Code: NHA
• Regulation Number: 872.3630
• Type: Special
• Panel: DE
• Reference & Predicate Devices: K072151

Intended Use

Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges and overdentures. The P.004 NC CARES Titanium Abutment is indicated for cement-retained restorations. The abutment can be used in single tooth replacements and multiple tooth restorations. The P.004 NC CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The abutment is indicated for cemented or screw-retained (directly veneered) restorations.

Device Description

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.

AI/ML Overview

The provided document is a 510(k) summary for a dental abutment device. It does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

The document primarily focuses on establishing substantial equivalence to a predicate device based on similar intended use, material composition, basic design, and fundamental operating principles. It is a regulatory submission for premarket notification, not a report of a rigorous scientific study with acceptance criteria and statistical analysis.

Therefore, I cannot provide the requested information from the given text.

To be explicit about the absence of information for each point requested:

1. A table of acceptance criteria and the reported device performance: Not present. The submission focuses on substantial equivalence, not performance against specific criteria.
2. Sample size used for the test set and the data provenance: Not present. No test set data is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment process is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not present. No test set or adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present. This device is a dental abutment, not an AI diagnostic tool, so an MRMC study with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This device is a dental abutment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present. No ground truth is mentioned.
8. The sample size for the training set: Not present. This device is a physical product, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established: Not present. Not applicable for this type of device.

Regulation Number and Section

§ 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.)