Cleared Traditional

K200764 - STATSTIX (FDA 510(k) Clearance)

K200764 · Centrix Incorporated · Dental device
Oct 2020
Decision
205d
Days
-
Risk

K200764 is an FDA 510(k) clearance for the STATSTIX. This device is classified as a Cord, Retraction.

Submitted by Centrix Incorporated (Shelton, US). The FDA issued a Cleared decision on October 15, 2020, 205 days after receiving the submission on March 24, 2020.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K200764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2020
Decision Date October 15, 2020
Days to Decision 205 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code MVL - Cord, Retraction
Device Class -