FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Silver Fluoride Hypersensitivity Varnish
K Number: K241041
·
Decision Feb 28, 2025
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
7
Applicant Total
16
Review Days
318
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Basic Information
- Device Name
- Silver Fluoride Hypersensitivity Varnish
- K Number
- K241041
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3260
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Young Dental Manufacturing Co. 1, LLC
- Date Received
- April 16, 2024
- Decision Date
- February 28, 2025
- Product Code
- PHR
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| PHR | Diammine Silver Fluoride Dental Hypersensitivity Varnish | FDA class 2 | Dental |
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