Cleared Traditional

Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials

K162948 · Kerr Corporation · Dental

Aug 2017

Decision

291d

Days

—

Risk

About This 510(k) Submission

K162948 is an FDA 510(k) clearance for the Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials, a Cord, Retraction, submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on August 8, 2017, 291 days after receiving the submission on October 21, 2016. This device falls under the Dental review panel.

Submission Details

510(k) Number	K162948 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 21, 2016
Decision Date	August 08, 2017
Days to Decision	291 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF