Clearance Summary
Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste received FDA 510(k) clearance under submission number K142549, sponsored by J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2015-05-26.
- Submission: K142549
- Applicant / Sponsor: J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2015-05-26
Classification & Regulation
This clearance is catalogued under FDA product code LFD , within the Unknown review panel as a device.