Manufacturer registered with FDA
newton implant systems
San Diego, CA, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 22024–2024
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What newton implant systems currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | implant, endosseous, root-formNi2 Newton Implant Systems | 2024 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | accessories, implant, dental, endosseous | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names newton implant systems as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 11 Apr 2024 | K221847 | Ni2 Implant System | DZE Root-Form Endosseous Implant |
| 18 Jan 2024 | K221866 | S-Plant Dental Implant System | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: IDIS Co. Ltd. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NEWTON IMPLANT SYSTEMSFDA reg. 3016784205 | Vista, CA, United States | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10085841). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.