FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Pulpdent (Activa) Pit and Fissure Sealant with MCP
K Number: K172169
·
Decision Jan 5, 2018
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
32
Review Days
171
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Basic Information
- Device Name
- Pulpdent (Activa) Pit and Fissure Sealant with MCP
- K Number
- K172169
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pulpdent Corporation
- Date Received
- July 18, 2017
- Decision Date
- January 5, 2018
- Product Code
- EBC
- 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 |
|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | FDA class 2 | Dental |
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