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K Number
K082764
Device Name
STRAUMANN WN CARES TITANIUM ABUTMENT
Manufacturer
INSTITUT STRAUMANN AG
Date Cleared
2008-10-01

(9 days)

Product Code
NHA
Regulation Number
872.3630
Type
Special
Panel
DE
Reference & Predicate Devices
K052272
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, bridges or overdentures. The Straumann WN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.

Device Description

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, abutments and surgical and prosthetic parts and instruments.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental abutment, not a study evaluating a device's performance against acceptance criteria using AI or advanced analytical methods. Therefore, I cannot extract the requested information as it is not present in the given document.

The document focuses on:

  • Device Identification: Straumann WN CARES Titanium Abutment.
  • Intended Use: To support prosthetic restorations (crowns, bridges) in dental implants for single or multiple tooth replacements.
  • Predicate Device: RN CARES Titanium Abutment (K052272).
  • Substantial Equivalence Claim: The new device is substantially equivalent to the predicate device in material composition, design, and operating principles.
  • Regulatory Classification: Class II under 21 CFR 872.3630 (Endosseous Dental Implant Abutment).
  • FDA Clearance: The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

There is no mention of acceptance criteria, a study proving device performance, sample sizes for test or training sets, ground truth establishment, expert adjudication, or any AI or MRMC comparative effectiveness study.

§ 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.)