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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

GlasIonomer FX-LC

Manufacturer

Shofu Dental Corporation

Date Cleared

2025-12-09

(97 days)

Product Code

Regulation Number

Type

Panel

Age Range

All

Reference & Predicate Devices

N/A

Predicate For

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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Restorations of deciduous teeth
Non-load bearing Class I and Class II restorations in permanent teeth
Restorations of Class V cavities and wedge-shaped defects

Device Description

Not Found

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