Cleared Traditional

K181839 - CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray (FDA 510(k) Clearance)

K181839 · Oralabs, Inc. · Dental device
Nov 2019
Decision
498d
Days
-
Risk

K181839 is an FDA 510(k) clearance for the CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray. This device is classified as a Saliva, Artificial.

Submitted by Oralabs, Inc. (Parker, US). The FDA issued a Cleared decision on November 21, 2019, 498 days after receiving the submission on July 11, 2018.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K181839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2018
Decision Date November 21, 2019
Days to Decision 498 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LFD - Saliva, Artificial
Device Class -