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510(k) K222253

GlasIonomer FX ULTRA by Shofu Dental Corporation — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2022
Date Received
July 27, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

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  • K251578 — BEAUTIFIL II (May 27, 2025)
  • K233161 — BeautiLink SA (September 28, 2023)
  • K213965 — BeautiBond Xtreme (March 18, 2022)
  • K212939 — Vintage Prime Press (March 18, 2022)
  • K200470 — Shofu Block HC Hard (February 5, 2021)
  • K191794 — Vintage Art Universal (October 3, 2019)
  • K182869 — Fit SA (January 9, 2019)

Other clearances for product code EMA

  • K254063 — iCEM Universal Plus (December 19, 2025)
  • K252785 — TopCEM Vigor SA Self-Adhesive Resin Cement (December 12, 2025)
  • K252808 — GlasIonomer FX-LC (December 9, 2025)
  • K252165 — ZIRCONOMER P (October 28, 2025)
  • K250953 — EQUIA LC ONE (September 19, 2025)
  • K251775 — RODIN Cement (September 2, 2025)
  • K251470 — ResiCem EX (July 11, 2025)
  • K250156 — Choice 2 DC (July 11, 2025)
  • K250566 — EsCem RMGI (June 20, 2025)
  • K242366 — OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abut (January 10, 2025)