Cleared Traditional

K152406 - SalivaMAX (FDA 510(k) Clearance)

K152406 · Forward Science, LLC · Dental device
Dec 2015
Decision
120d
Days
-
Risk

K152406 is an FDA 510(k) clearance for the SalivaMAX. This device is classified as a Saliva, Artificial.

Submitted by Forward Science, LLC (Stafford, US). The FDA issued a Cleared decision on December 23, 2015, 120 days after receiving the submission on August 25, 2015.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K152406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2015
Decision Date December 23, 2015
Days to Decision 120 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LFD - Saliva, Artificial
Device Class -