Cleared Traditional

K173808 - Voutia

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

FDA 510(k) Submission Details - K173808

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 127d · This submission: 224d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 17
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