The following data is part of a premarket notification filed by J.c.e.c. Company, Inc. (doing Business As Fountain Health Ca with the FDA for Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste.
| Device ID | K142549 |
| 510k Number | K142549 |
| Device Name: | Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste |
| Classification | Saliva, Artificial |
| Applicant | J.C.E.C. Company, Inc. (doing Business As Fountain Health Ca 12 Frieda Lane Kendall Park, NJ 08824 |
| Contact | John Canvin |
| Correspondent | Elizabeth N. Dupras B&H Consulting Services, Inc. 50 Division Street, Suite 206 Somerville, NJ 08876 |
| Product Code | LFD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-10 |
| Decision Date | 2015-05-26 |
| Summary: | summary |