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K Number
K072151
Device Name
P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS
Manufacturer
STRAUMANN USA
Date Cleared
2007-09-11

(39 days)

Product Code
NHA
Regulation Number
872.3630
Type
Traditional
Panel
DE
Reference & Predicate Devices
K052272,K061277,K062129
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns or bridges. The P.004 RC CARES Titanium Abutment is indicated for cemented restoration. The abutment can be used in single tooth replacements and multiple tooth restorations.

Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns or bridges. The P.004 RC CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw retained.

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 text is a 510(k) summary for a dental abutment device. Based on the content, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or clinical comparative effectiveness studies. The document primarily focuses on establishing substantial equivalence to predicate devices, material composition, intended use, and technological characteristics.

Therefore, I cannot populate the requested table and answer the questions. The relevant sections of the document explicitly state:

  • "The proposed 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."

This indicates that the submission relies on the established safety and effectiveness of predicate devices rather than presenting new performance data from a specific study of the new device against acceptance criteria.

§ 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.)