LogoFDA 510(k) Search
K Number
K120779
Device Name
STRUCTUR 3
Manufacturer
VOCO GMBH
Date Cleared
2012-06-01

(79 days)

Product Code
EBG
Regulation Number
872.3770
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Structur 3 is intended for use as:

  • fabrication of temporary crowns, bridges, inlays, onlays, partial crowns, veneers and temporary posts
  • fabrication of long-term temporary restorations -
  • rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal
Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) cleared by the FDA for the medical device "Structur 3", a temporary crown and bridge resin. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm or performance evaluation.

The document primarily focuses on:

  • The FDA's determination of substantial equivalence for the Structur 3 device to a legally marketed predicate device.
  • Regulatory information, including general controls provisions, additional controls for Class II/III devices, and compliance requirements.
  • Contact information for FDA offices.
  • The Indications for Use Statement for Structur 3, which outlines its intended applications (fabrication of temporary crowns, bridges, inlays, etc., and rebasing prefabricated temporary crowns).

Therefore, I cannot provide the requested information as it is not present in the given text. The request seems to be looking for details typically found in a clinical study report or a technical performance evaluation document for an AI/ML medical device, which this document is not.

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.