Cleared Traditional

K254239 - CyClean Cord (FDA 510(k) Clearance)

K254239 · SS GLOBAL · Dental device

Mar 2026

Decision

88d

Days

Risk

K254239 is an FDA 510(k) clearance for the CyClean Cord. This device is classified as a Cord, Retraction.

Submitted by SS GLOBAL (Bucheon-Si, KR). The FDA issued a Cleared decision on March 27, 2026, 88 days after receiving the submission on December 29, 2025.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number	K254239 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 29, 2025
Decision Date	March 27, 2026
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF