Cleared Traditional

K150074 - Elevate Moisturizing Spray

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

FDA 510(k) Submission Details - K150074

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 128d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 43
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K150074.
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K142549 · J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA · May 2015
ORAMOIST
K122663 · Quantum, Inc. · May 2013
BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
K123731 · Glaxosmithkline Consumer Healthcare (Gskch) · Jan 2013