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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 the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corporation. It received FDA 510(k) clearance on 2025-12-09 under 510(k) 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. The listed applicant is Shofu Dental Corporation. The 510(k) number is K252808.

When did GlasIonomer FX-LC receive FDA 510(k) clearance?

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

Who is the listed applicant for GlasIonomer FX-LC?

The FDA 510(k) record lists Shofu Dental Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Shofu Dental Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252165ZIRCONOMER PK251470ResiCem EXK251578BEAUTIFIL IIK233161BeautiLink SAK222253GlasIonomer FX ULTRAK213965BeautiBond Xtreme

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Related Devices (Code: EMA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH

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.

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