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510(k) Data Aggregation

K Number

Device Name

GlasIonomer FX ULTRA

Manufacturer

Shofu Dental Corporation

Date Cleared

2022-09-22

(57 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

GlasIonomer FX ULTRA

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Restoration of deciduous teeth
Non-load bearing Class I and Class II restorations in permanent teeth
Restoration of Class III and Class V cavities and wedge shaped defects
Core build-up

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for a dental cement called "GlasIonomer FX ULTRA". It does not contain any information about acceptance criteria, study details, or performance of an AI/ML powered medical device. Therefore, I cannot generate the requested response.

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