Cleared Traditional

RE / STASIS (TM) GINGIVAL RETRACTION PASTE

K111348 · Centrix, Inc. · Dental

Jul 2011

Decision

70d

Days

—

Risk

About This 510(k) Submission

K111348 is an FDA 510(k) clearance for the RE / STASIS (TM) GINGIVAL RETRACTION PASTE, a Cord, Retraction, submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on July 22, 2011, 70 days after receiving the submission on May 13, 2011. This device falls under the Dental review panel.

Submission Details

510(k) Number	K111348 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 13, 2011
Decision Date	July 22, 2011
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement