Cleared Traditional

K173808 - Voutia™ (FDA 510(k) Clearance)

K173808 · Jeffrey Ward Cash, Dds · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
224d
Days
-
Risk

K173808 is an FDA 510(k) clearance for the Voutia™. Classified as Saliva, Artificial (product code LFD).

Submitted by Jeffrey Ward Cash, Dds (North Chesterfield, US). The FDA issued a Cleared decision on July 27, 2018 after a review of 224 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 Jeffrey Ward Cash, Dds devices

Submission Details

510(k) Number K173808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2017
Decision Date July 27, 2018
Days to Decision 224 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
97d slower than avg
Panel avg: 127d · This submission: 224d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 49
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K173808.
Allday Moisturizing Rinse
K253778 · Elevate Oral Care · Feb 2026
CloSYS® Dry Mouth Sensitive Mouth Rinse
K250390 · Rowpar Pharmaceuticals, Inc. · May 2025
Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
K240508 · Laclede, Inc. · Apr 2024
Caphosol® Artifical Saliva (32 doses sachet box)
K234015 · Eusa Pharma (Uk) Limited · Mar 2024
GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
K231205 · Gurunanda, LLC · Aug 2023
Dentilube Spray
K202689 · Oxy2plus, LLC · Sep 2021