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K Number
K042715
Device Name
TITAN DENTAL IMPLANT ATTACHMENT
Manufacturer
TITAN IMPLANTS, INC.
Date Cleared
2005-03-23

(174 days)

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

Abutments are intended to be placed into dental implants as support for prosthetic reconstructions such as crowns and bridges. The abutments are indicated for cemented restoration in areas of the mouth and used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.

Device Description

The Titan Dental Implant Attachments and accessories are an integrated system of endosseous implant abutments, which are designed to support prosthetic devices for partially, or fully edentulous patients. The system consists of a variety of dental implant abutments and accessories. The devices covered in this submission include abutments, combination transfer coping/permanent abutments and miscellaneous accessories.

AI/ML Overview

I'm sorry, but based on the provided document, I cannot fulfill your request for information about acceptance criteria and a study proving device performance.

Here's why:

  • The document is a 510(k) clearance letter. This type of document from the FDA indicates that a device has been found substantially equivalent to a predicate device already on the market. It does not typically contain detailed information about performance studies, acceptance criteria, or specific clinical trial results.
  • The content focuses on regulatory classification and substantial equivalence. The provided text discusses the device name, classification, intended use, and the FDA's determination that it is substantially equivalent to existing devices. There's no mention of performance metrics, study designs, sample sizes, or ground truth establishment.
  • The device is an "Endosseous Dental Implant Abutment." For devices like this, the 510(k) clearance often relies heavily on material equivalence, design equivalence, and established safety and effectiveness of the predicate device, rather than new, extensive clinical performance studies with specific statistical acceptance criteria for "device performance" in the way one might see for an AI diagnostic tool, for example.

Therefore, the specific information requested in your numbered points (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) is not present in the provided 510(k) summary.

§ 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.)