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510(k) K260819

Any-Com Seal by Mediclus Co., Ltd. — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2026
Date Received
March 13, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sealant, Pit And Fissure, And Conditioner
Device Class
Class II
Regulation Number
872.3765
Review Panel
DE
Submission Type

Other clearances by Mediclus Co., Ltd.

  • K260485 — Any-Etch (May 14, 2026)
  • 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)
  • K251283 — Once-Fil Flow (June 6, 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)

Other clearances for product code EBC

  • K243254 — Parkell Pit and Fissure Sealant (August 8, 2025)
  • K232498 — UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection b (August 18, 2023)
  • K230455 — Enamel Coating Resin (July 25, 2023)
  • K190998 — BA Pit & Fissure Sealant (November 8, 2019)
  • K190339 — Helioseal F Plus (July 29, 2019)
  • K172169 — Pulpdent (Activa) Pit and Fissure Sealant with MCP (January 5, 2018)
  • K171330 — Nanova Sealant (September 8, 2017)
  • K162598 — HAPI Seal (May 23, 2017)
  • K161580 — Premier Sealant (October 18, 2016)
  • K141717 — PACSEAL PIT & FISSURE SEALANT (March 9, 2015)