Cleared Traditional

Retraxil

K243910 · Kulzer, LLC · Dental
Sep 2025
Decision
279d
Days
—
Risk

About This 510(k) Submission

K243910 is an FDA 510(k) clearance for the Retraxil, a Cord, Retraction, submitted by Kulzer, LLC (South Bend, US). The FDA issued a Cleared decision on September 24, 2025, 279 days after receiving the submission on December 19, 2024. This device falls under the Dental review panel.

Submission Details

510(k) Number K243910 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2024
Decision Date September 24, 2025
Days to Decision 279 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code MVL — Cord, Retraction
Device Class —