Cleared Traditional

K181194 - SmartMouth DryMouth Oral Rinse (FDA 510(k) Clearance)

K181194 · Triumph Pharmaceuticals, Inc. · Dental device
Feb 2019
Decision
287d
Days
-
Risk

K181194 is an FDA 510(k) clearance for the SmartMouth DryMouth Oral Rinse. Classified as Saliva, Artificial (product code LFD).

Submitted by Triumph Pharmaceuticals, Inc. (St. Louis, US). The FDA issued a Cleared decision on February 15, 2019 after a review of 287 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.

Submission Details

510(k) Number K181194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2018
Decision Date February 15, 2019
Days to Decision 287 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 158d · This submission: 287d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -