Cleared Traditional

K111250 - DRY MOUTH MOUTHWASH

K111250 · Dr. Fresh, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
231d slower than avg
Panel avg: 128d · 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 46
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K111250.
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
AIR LIFT/XEROSTOM ARTIFICIAL SALIVA
K120552 · Biocosmetics Laboratories · Jun 2012
BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
K103745 · Glaxosmithkline Consumer Healthcare (Gskch) · Jul 2011
XEROS DRY MOUTH PUMP
K110116 · Lorin Technologies Corporation · Apr 2011
GC ORAL MOISTURIZING GEL
K101346 · GC America, Inc. · Jan 2011
K111250 · DRY MOUTH MOUTHWASH
Download PDF FDA Summary Dr. Fresh, Inc.