GlasIonomer FX-LC— 510(k) K252808

Substantially Equivalent

Shofu Dental Corporation

FDA 510(k) clearance K252808 for GlasIonomer FX-LC, Substantially Equivalent on 2025-12-09. Applicant: Shofu Dental Corporation. Device class: 2.

Clearance details

Applicant: Shofu Dental Corporation
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2025-09-03
Decision date: 2025-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Marcos, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EMA

K254201 — Any-Cem2026-08-13
K261937 — PacTemp Automix NE2026-08-07
K261166 — DIA-CEM2026-07-09
K254109 — G-CEM UNIVERSAL2026-05-18
K253337 — REGEN Bioactive Cement2026-04-15

More clearances from Shofu Dental Corporation

K252165 — ZIRCONOMER P2025-10-28
K251470 — ResiCem EX2025-07-11
K251578 — BEAUTIFIL II2025-05-27
K233161 — BeautiLink SA2023-09-28
K222253 — GlasIonomer FX ULTRA2022-09-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.