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510(k) K250566

EsCem RMGI by Spident Co., Ltd. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2025
Date Received
February 26, 2025
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 Spident Co., Ltd.

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  • K241445 — K-Bond Universal (July 22, 2024)
  • K231523 — EsCom250 (July 24, 2023)
  • K214076 — EsCem (December 19, 2022)
  • K214071 — Hexa-Temp (March 10, 2022)
  • K161774 — i-Sil (September 30, 2016)
  • K134022 — BASE IT (June 11, 2014)
  • K134021 — ESTEMP IMPLANT, ESTEMP CLEAR (June 10, 2014)

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)
  • K242366 — OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abut (January 10, 2025)
  • K240714 — Insure® Universal; Insure® Universal Automix (July 24, 2024)