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K Number
K984467
Device Name
FUSICRYL
Manufacturer
MICRO DENTAL LABORATORIES
Date Cleared
1999-02-24

(70 days)

Product Code
EBI
Regulation Number
872.3760
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Fabrication of dental prostheses like full dentures and metal free partials.

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for a dental material named "FUSICRYL". It indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).

Therefore, I cannot provide the requested information. The document focuses solely on the regulatory clearance of the device based on substantial equivalence, not on the detailed technical performance data that would typically be found in a study report.

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.