K221847
- 510(k) number
- K221847
- Device name
- Ni2 Implant System
- Applicant
- Newton Implant Systems, Inc. CA · US
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2024-04-11
- Date received
- 2022-06-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K221847.pdf
Official FDA record: K221847
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.