FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Allday Moisturizing Rinse
K Number: K253778
·
Decision Feb 27, 2026
Classifications
1
FEI Numbers
39
Registration Numbers
40
Same Product Code
49
Applicant Total
4
Review Days
93
Basic Information
- Device Name
- Allday Moisturizing Rinse
- K Number
- K253778
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elevate Oral Care
- Date Received
- November 26, 2025
- Decision Date
- February 27, 2026
- 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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