Cleared Traditional

K142549 - Oral7 Moisturizing Gel

K142549 · J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
258d
Days
-
Risk

K142549 is an FDA 510(k) clearance for the Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mout.... Classified as Saliva, Artificial (product code LFD).

Submitted by J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA (Kendall Park, US). The FDA issued a Cleared decision on May 26, 2015 after a review of 258 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 J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA devices

FDA 510(k) Submission Details - K142549

510(k) Number K142549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2014
Decision Date May 26, 2015
Days to Decision 258 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
131d slower than avg
Panel avg: 127d · This submission: 258d
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 K142549.
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