Cleared Traditional

K150074 - Elevate Moisturizing Spray (FDA 510(k) Clearance)

K150074 · Elevate Oral Care · Dental device
Jun 2015
Decision
156d
Days
—
Risk

K150074 is an FDA 510(k) clearance for the Elevate Moisturizing Spray. This device is classified as a Saliva, Artificial.

Submitted by Elevate Oral Care (West Palm Beach, US). The FDA issued a Cleared decision on June 19, 2015, 156 days after receiving the submission on January 14, 2015.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K150074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2015
Decision Date June 19, 2015
Days to Decision 156 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LFD — Saliva, Artificial
Device Class —