Cleared Traditional

K093711 - RACEGEL (FDA 510(k) Clearance)

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

K093711 is an FDA 510(k) clearance for the RACEGEL. This device is classified as a Cord, Retraction.

Submitted by Septodont (Washington, US). The FDA issued a Cleared decision on February 17, 2010, 78 days after receiving the submission on December 1, 2009.

This device falls under the Dental FDA review panel.

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

Device Classification

Product Code MVL - Cord, Retraction
Device Class -