Cleared Traditional

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

K150074 · Elevate Oral Care · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
156d
Days
-
Risk

K150074 is an FDA 510(k) clearance for the Elevate Moisturizing Spray. Classified as Saliva, Artificial (product code LFD).

Submitted by Elevate Oral Care (West Palm Beach, US). The FDA issued a Cleared decision on June 19, 2015 after a review of 156 days - an extended review cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Elevate Oral Care devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 127d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 17
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K150074.
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. · Jul 2018
Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist
K173237 · Syendgen, Inc. · Mar 2018
TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
K171542 · Dr. Harold Katz, LLC (Dba Therabreath · Mar 2018
GC ORAL MOISTURIZING GEL
K101346 · GC America, Inc. · Jan 2011