# K221847: Ni2 Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Newton Implant Systems, Inc.
- Decided: Apr 11, 2024 after 657 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K894595 (1990). 264 ancestors in all.
No later device cites it as a predicate yet.
0 of 265 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221866: S-Plant Dental Implant System, Newton Implant Systems, Inc. (2024). Cleared while this submission was under review Summary page 5.

## Indications for use
The Ni2 Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The smaller Ni2 dental implants (Ø3.6, 4.0, 5.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading. The larger Ni2 Implants (Ø6.0, 7.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.

Source page: https://510kreport.com/device/K221847
Methodology: https://510kreport.com/methodology