FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Bonafix Implant Abutments
K Number: K251294
·
Decision Oct 15, 2025
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
3
Review Days
173
Basic Information
- Device Name
- Bonafix Implant Abutments
- K Number
- K251294
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zentek Medical, LLC
- Date Received
- April 25, 2025
- Decision Date
- October 15, 2025
- Product Code
- NHA
- 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
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