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510(k) K214076

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2022
Date Received
December 27, 2021
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.

  • K250566 — EsCem RMGI (June 20, 2025)
  • K250317 — EsFlow PLUS (May 30, 2025)
  • K242702 — VioSeal (November 7, 2024)
  • K242675 — FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, (November 1, 2024)
  • K241445 — K-Bond Universal (July 22, 2024)
  • K231523 — EsCom250 (July 24, 2023)
  • 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)
  • 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)