Cleared Traditional

DRY MOUTH MOUTHWASH (K111250) - FDA 510(k) Clearance

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

Submission Details

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.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 49
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