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510(k) K200798

G-CEM ONE by GC America, Inc. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2020
Date Received
March 26, 2020
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

Other clearances by GC America, Inc.

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  • K200682 — BZF-29 (October 2, 2020)
  • K192597 — Cytrans Granules (August 17, 2020)
  • K193113 — GC Temp Print (July 9, 2020)
  • K193484 — GC Fuji Triage EP (July 2, 2020)
  • K192260 — everX Flow (November 22, 2019)
  • K182854 — GC FujiCEM 2 (Improved) (July 11, 2019)
  • K180917 — GC Acrylic Primer (November 20, 2018)

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)
  • K250156 — Choice 2 DC (July 11, 2025)
  • K251470 — ResiCem EX (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)