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510(k) K254239

CyClean Cord by SS GLOBAL — Product Code MVL

K254239 is an FDA 510(k) premarket notification submitted by SS GLOBAL for the device "CyClean Cord". The FDA issued a decision of Substantially Equivalent on March 27, 2026. The device falls under product code MVL (Cord, Retraction), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2026
Date Received
December 29, 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 for product code MVL

  • K253797 — One-Stop (February 27, 2026)
  • 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)

FDA data resources