FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEN5 and GEN5+ Dental Implant System
K Number: K251938
·
Decision Oct 30, 2025
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
4
Review Days
128
Basic Information
- Device Name
- GEN5 and GEN5+ Dental Implant System
- K Number
- K251938
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Paragon Implant Mfg., LLC
- Date Received
- June 24, 2025
- Decision Date
- October 30, 2025
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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