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510(k) K251283

Once-Fil Flow by Mediclus Co., Ltd. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2025
Date Received
April 25, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

Other clearances by Mediclus Co., Ltd.

  • K253797 — One-Stop (February 27, 2026)
  • K253167 — Any-Paste (January 12, 2026)
  • K252465 — Any-Core (December 5, 2025)
  • K251884 — One-Fil Putty Injectable (August 22, 2025)
  • K250823 — Any-Com Flow (April 14, 2025)
  • K243353 — One-Fil Putty (March 14, 2025)
  • K242713 — Any-Com Bulk (February 7, 2025)
  • K241147 — Any-Com (September 26, 2024)
  • K232182 — One-Fil (January 26, 2024)
  • K230465 — Hi-Bond Universal (May 22, 2023)

Other clearances for product code EBF

  • K260783 — Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One (March 11, 2026)
  • K254245 — ZAFIRA® (March 3, 2026)
  • K260170 — LumiCera (January 21, 2026)
  • K252465 — Any-Core (December 5, 2025)
  • K253513 — MultiMatch Flow Chameleon AntiMicrobial Composite (November 7, 2025)
  • K253236 — G-BLOCK (September 29, 2025)
  • K253053 — Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (September 23, 2025)
  • K251946 — G aenial Universal Injectable II (August 29, 2025)
  • K250317 — EsFlow PLUS (May 30, 2025)
  • K251578 — BEAUTIFIL II (May 27, 2025)