Cleared Traditional

G?U?M HYDRAL Dry Mouth Oral Gel, G?U?M HYDRAL Dry Mouth Oral Rinse, G?U?M HYDRAL Dry Mouth Oral Spray

K181134 · Sunstar Americas, Inc. · Dental

Jul 2018

Decision

74d

Days

—

Risk

About This 510(k) Submission

K181134 is an FDA 510(k) clearance for the G?U?M HYDRAL Dry Mouth Oral Gel, G?U?M HYDRAL Dry Mouth Oral Rinse, G?U?M HYDRAL Dry Mouth Oral Spray, a Saliva, Artificial, submitted by Sunstar Americas, Inc. (Schaumburg, US). The FDA issued a Cleared decision on July 13, 2018, 74 days after receiving the submission on April 30, 2018. This device falls under the Dental review panel.

Submission Details

510(k) Number	K181134 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 2018
Decision Date	July 13, 2018
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF