FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Papacarie Duo
K Number: K233768
·
Decision Jul 18, 2024
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
137
Applicant Total
4
Review Days
237
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Basic Information
- Device Name
- Papacarie Duo
- K Number
- K233768
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3260
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elevate Oral Care
- Date Received
- November 24, 2023
- Decision Date
- July 18, 2024
- Product Code
- LBH
- 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 |
|---|---|---|---|
| LBH | Varnish, Cavity | FDA class 2 | Dental |
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