Cleared Traditional

Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray

K180680 · Laclede, Inc. · Dental
Oct 2018
Decision
210d
Days
—
Risk

About This 510(k) Submission

K180680 is an FDA 510(k) clearance for the Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray, a Saliva, Artificial, submitted by Laclede, Inc. (Rancho Dominguez, US). The FDA issued a Cleared decision on October 11, 2018, 210 days after receiving the submission on March 15, 2018. This device falls under the Dental review panel.

Submission Details

510(k) Number K180680 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2018
Decision Date October 11, 2018
Days to Decision 210 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LFD — Saliva, Artificial
Device Class —

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