Cleared Traditional

K253797 - One-Stop (FDA 510(k) Clearance)

K253797 · Mediclus Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
91d
Days
-
Risk

K253797 is an FDA 510(k) clearance for the One-Stop. Classified as Cord, Retraction (product code MVL).

Submitted by Mediclus Co., Ltd. (Cheongju-Si, KR). The FDA issued a Cleared decision on February 27, 2026 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Mediclus Co., Ltd. devices

Submission Details

510(k) Number K253797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2025
Decision Date February 27, 2026
Days to Decision 91 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
36d faster than avg
Panel avg: 127d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -