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K Number
K043493
Device Name
FUSION PUTTY TYPE
Manufacturer
GC AMERICA, INC.
Date Cleared
2005-03-04

(77 days)

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

This product is a high consistency vinylpolysiloxane impression material to be used for taking intra-oral impressions.

Device Description

Not Found

AI/ML Overview

The document provided is a 510(k) premarket notification letter from the FDA for a device called "FUSION PUTTY," an impression material. It determines substantial equivalence to a predicate device but does not contain information about acceptance criteria, device performance, or a study that proves the device meets specific criteria.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study from the provided document. The document is essentially an approval letter based on equivalence, not a performance study report.

§ 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).