Cleared Traditional

K142549 - Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 128d · This submission: 258d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Consultant

B&H Consulting Services, Inc.
Elizabeth N. Dupras

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LFD Saliva, Artificial

All 45
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K142549.
SalivaMAX
K152406 · Forward Science, LLC · Dec 2015
XEROSTOM SALIVA SUBSTITUTE GEL
K142657 · Bio Cosmetics, S.L. · Sep 2015
Elevate Moisturizing Spray
K150074 · Elevate Oral Care · Jun 2015
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