FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FP3D
K Number: K250489
·
Decision May 20, 2025
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
329
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- FP3D
- K Number
- K250489
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Keystone Industries
- Date Received
- February 19, 2025
- Decision Date
- May 20, 2025
- Product Code
- EBI
- 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 |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | FDA class 2 | Dental |
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