Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste— 510(k) K142549

Substantially Equivalent

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

FDA 510(k) clearance K142549 for Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste, Substantially Equivalent on 2015-05-26. Applicant: J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA.

Clearance details

Applicant: J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA
Product code: Code LFD
Advisory panel: Unknown
Date received: 2014-09-10
Decision date: 2015-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kendall Park, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LFD

product code LFD

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.