Data / Medical devices / United States / Newton Implant Systems
Newton Implant Systems: FDA-registered device maker in Vista, CA, United States, 2 510(k) clearances
Newton Implant Systems is registered with the FDA (registration 3016784205) in Vista, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 11, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016784205
- Address
- 440 S. Melrose dr Suite 202, Vista, CA, United States, 92081
- Owner or operator
- newton implant systems (10085841)
- Roles
- Specification developer
- First device listed
- August 10, 2023
- Registered through
- 2026
- Brand names listed
- Ni2 Newton Implant Systems, accessories, implant, dental, endosseous, implant, endosseous, root-form
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Specification developer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 11, 2024 | K221847 | Ni2 Implant System | DZE | Substantially Equivalent | Newton Implant Systems, Inc. | accessdata.fda.gov |
| January 18, 2024 | K221866 | S-Plant Dental Implant System | DZE | Substantially Equivalent | Newton Implant Systems, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 11, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.