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510(k) Data Aggregation

K Number

Device Name

Manufacturer

GC America Inc.

Date Cleared

2025-09-19

(175 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K172382,K993973,K130223

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Class I, II, III, IV and V restorations
Root surface restoration
Core build-up

Device Description

EQUIA LC ONE is a resin-modified glass ionomer dental restorative material which is intended to be used as a restorative filling material for direct restorations and or core buildups. The applicant device is provided as a powder/liquid formulation in a mixing capsule.

AI/ML Overview

N/A

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