FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
SaliPen
K Number: K220618
·
Decision Aug 30, 2022
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
4
Review Days
180
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Basic Information
- Device Name
- SaliPen
- K Number
- K220618
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5560
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Saliwell , Ltd.
- Date Received
- March 3, 2022
- Decision Date
- August 30, 2022
- Product Code
- QTT
- 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 |
|---|---|---|---|
| QTT | Over The Counter Electrical Salivary Stimulatory System | FDA class 2 | Dental |
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