K-number	K252808
Device name	GlasIonomer FX-LC
Applicant	Shofu Dental Corporation
Product code	EMA
Device class	Class II
Decision date	Dec 9, 2025
Decision	Substantially Equivalent
Regulation	872.3275

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

GlasIonomer FX-LC is a light-cured dental cement classified as a Class II device. It is indicated for restorations of deciduous teeth, non-load bearing Class I and Class II restorations in permanent teeth, and restorations of Class V cavities and wedge-shaped defects. The device is for prescription use by dental professionals.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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GlasIonomer FX-LC

Everything you need for a 510(k) submission. Nothing you don't.