Cleared Traditional

K111250 - DRY MOUTH MOUTHWASH

K111250 · Dr. Fresh, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
359d
Days
-
Risk

K111250 is an FDA 510(k) clearance for the DRY MOUTH MOUTHWASH. Classified as Saliva, Artificial (product code LFD).

Submitted by Dr. Fresh, Inc. (Hampton, US). The FDA issued a Cleared decision on April 27, 2012 after a review of 359 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Dr. Fresh, Inc. devices

FDA 510(k) Submission Details - K111250

510(k) Number K111250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2011
Decision Date April 27, 2012
Days to Decision 359 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
232d slower than avg
Panel avg: 127d · This submission: 359d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 18
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K111250.
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
GLANDOSANE (SALIVART) SYNTHETIC SALIVA
K874106 · Fresenius USA, Inc. · Apr 1988