Home / 510(k) Clearances / K253797

510(k) K253797

One-Stop by Mediclus Co., Ltd. — Product Code MVL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2026
Date Received
November 28, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cord, Retraction
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances by Mediclus Co., Ltd.

  • 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)
  • K232182 — One-Fil (January 26, 2024)
  • K230465 — Hi-Bond Universal (May 22, 2023)

Other clearances for product code MVL

  • K243910 — Retraxil (September 24, 2025)
  • K211420 — Stasis Gel (March 14, 2022)
  • K211419 — Gingi-Aid Gel (January 10, 2022)
  • K213149 — VOCO Retraction Paste (December 9, 2021)
  • K200764 — STATSTIX (October 15, 2020)
  • K193389 — Vista Clear (March 4, 2020)
  • K190220 — Vista FS, Vista FS Liquid (June 10, 2019)
  • K171577 — Smartcord, Smartcord X (May 3, 2018)
  • K162662 — GingiDent Gingival Retraction Paste (October 20, 2017)
  • K162948 — Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retra (August 8, 2017)