Cleared Traditional

STATSTIX

K200764 · Centrix Incorporated · Dental

Oct 2020

Decision

205d

Days

—

Risk

About This 510(k) Submission

K200764 is an FDA 510(k) clearance for the STATSTIX, 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 review panel.

Submission Details

510(k) Number	K200764 FDA.gov
FDA Decision	Cleared 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