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510(k) Data Aggregation

K Number

Device Name

Manufacturer

Shofu Dental Corporation

Date Cleared

2025-10-28

(110 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Class I and II restorations in deciduous teeth
Class I, and non-stress bearing Class II restorations in permanent teeth
Stress bearing Class II restorations in permanent teeth, keeping ≥1 mm distance from the cusp tips

Device Description

Not Found

AI/ML Overview

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