FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste
K Number: K142549
·
Decision May 26, 2015
Classifications
1
FEI Numbers
39
Registration Numbers
40
Same Product Code
49
Applicant Total
1
Review Days
258
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Basic Information
- Device Name
- Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste
- K Number
- K142549
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA
- Date Received
- September 10, 2014
- Decision Date
- May 26, 2015
- Product Code
- LFD
- Advisory Committee
- Unknown
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LFD | Saliva, Artificial | FDA unclassified | Unknown |
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