FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ni2 Implant System
K Number: K221847
·
Decision Apr 11, 2024
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
2
Review Days
657
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Basic Information
- Device Name
- Ni2 Implant System
- K Number
- K221847
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Newton Implant Systems, Inc.
- Date Received
- June 24, 2022
- Decision Date
- April 11, 2024
- 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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Other Clearances by Newton Implant Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K221866 | S-Plant Dental Implant System | Jan 18, 2024 | Substantially Equivalent |