510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K142549Substantially Equivalent

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

J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA, Kendall Park NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142549 is the FDA 510(k) clearance record for Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste, cleared for J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA on under FDA product code LFD (Saliva, Artificial). FDA records list one 510(k) clearance for J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA. As of , FDA records show no recalls naming K142549.

Clearance record

Decision date
Received
(258 days to decision)
Product code
LFD Saliva, Artificial
Device class
Unclassified
Review panel
Unknown
Applicant
J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA 12 Frieda Ln., Kendall Park NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LFD

Trailing 12 months
1 clearance under product code LFD in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LFD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260