Cleared Traditional

K243910 - Retraxil (FDA 510(k) Clearance)

K243910 · Kulzer, LLC · Dental device
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Optimized for regulatory review, auditing and printing
Sep 2025
Decision
279d
Days
-
Risk

K243910 is an FDA 510(k) clearance for the Retraxil. Classified as Cord, Retraction (product code MVL).

Submitted by Kulzer, LLC (South Bend, US). The FDA issued a Cleared decision on September 24, 2025 after a review of 279 days - an extended review 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: 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.

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Submission Details

510(k) Number K243910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 127d · This submission: 279d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -