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K Number
K041398
Device Name
GC FUSION
Manufacturer
GC AMERICA, INC.
Date Cleared
2004-06-25

(30 days)

Product Code
ELW
Regulation Number
872.3660
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Product is a dental vinylpolysiloxane impression material intended for use of taking intra-oral impressions of a patient's mouth.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information needed to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a dental impression material named "GC FUSION."

While it confirms the device is substantially equivalent to legally marketed predicate devices, it does not include any specific performance specifications, acceptance criteria, or details about the studies conducted to demonstrate those criteria.

The document primarily focuses on:

  • The FDA's determination of substantial equivalence.
  • Regulatory information (regulation number, name, class, product code).
  • General controls and compliance requirements for the manufacturer.
  • The intended use of the device.

To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a detailed product submission that outlines the performance characteristics and the data supporting them.

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).