Cleared Traditional

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

K254239 · SS GLOBAL · Dental device
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Optimized for regulatory review, auditing and printing
Mar 2026
Decision
88d
Days
-
Risk

K254239 is an FDA 510(k) clearance for the CyClean Cord. Classified as Cord, Retraction (product code MVL).

Submitted by SS GLOBAL (Bucheon-Si, KR). The FDA issued a Cleared decision on March 27, 2026 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all SS GLOBAL devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -

Regulatory Consultant

LK Consulting Group USA, Inc.
Priscilla Chung

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.