Cleared Traditional

RACEGEL (K093711) - FDA 510(k) Clearance

K093711 · Septodont · Dental device
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Feb 2010
Decision
78d
Days
-
Risk

K093711 is an FDA 510(k) clearance for the RACEGEL. Classified as Cord, Retraction (product code MVL).

Submitted by Septodont (Washington, US). The FDA issued a Cleared decision on February 17, 2010 after a review of 78 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.

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Submission Details

510(k) Number K093711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2009
Decision Date February 17, 2010
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 127d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -