510(k) Report

FDA applicant

J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA

Kendall Park, NJ1 decision2015–20150 recalls

FDA records 1 decision for J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA (Kendall Park, NJ) in 2015: 1 510(k) clearance. All are in product code LFD (Saliva, Artificial). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like J.C.E.C. Company, Inc. (Doing Business…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LFDSaliva, Artificial1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142549Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 ToothpasteJ.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA · 20151cites it

What has FDA decided for it lately?

  • K142549Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 ToothpasteJ.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA · 2015

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