Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GlasIonomer FX-LC

K-Number: K252808 · 2025-12-09

ApplicantShofu Dental Corporation
Decision Date2025-12-09
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GlasIonomer FX-LC is a medical device manufactured by Shofu Dental Corporation. It received FDA 510(k) clearance on 2025-12-09 under approval number K252808. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GlasIonomer FX-LC?

GlasIonomer FX-LC is a medical device that received FDA 510(k) clearance on 2025-12-09. It is manufactured by Shofu Dental Corporation. The 510(k) number is K252808.

When was GlasIonomer FX-LC approved by the FDA?

GlasIonomer FX-LC received FDA 510(k) clearance on 2025-12-09, under approval number K252808.

What company makes GlasIonomer FX-LC?

GlasIonomer FX-LC is manufactured by Shofu Dental Corporation.

What is the FDA product code for GlasIonomer FX-LC?

The FDA product code for GlasIonomer FX-LC is EMA.

Other Devices by Shofu Dental Corporation

K161891HC Primer K160596BEAUTIFIL II LS K160086SHOFU Enamel Conditioner K151700BEAUTIFIL II Gingiva K152392VINTAGE LD K172530BEAUTIFIL Flow Plus X

View all 23 devices →

Related Devices (Code: EMA)

K160800DuoCemColtene/Whaledent AG K161851Glass Ionomer Cement (Luting)Shandong Huge Dental Material Corporation K160443TempoCem ClearDmg USA, Inc. K160774IonoStar PlusVoco GmbH K161256TheraCemBisco, Inc. K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑