# K221866: S-Plant Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Newton Implant Systems, Inc.
- Decided: Jan 18, 2024 after 570 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: 16 generations back to K894595 (1990). 263 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 266 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122519: Dio UF Hsa Internal Sub-Merged Implant System, Dio Corporation (2013) Summary page 5.
- K141457: Dentium Implantium and Superline Abutments, Dentium Co., Ltd. (2014) Summary page 5.
- K182091: Osstem Abutment System, Osstem Implant Co., Ltd. (2019) Summary page 5.
- K203360: EK Implants and Abutments System, Hiossen, Inc. (2022) Summary page 5.

## Most influential descendants
- K243731: HEXIM Implant; Samwon General Abutments (2025), 0 descendants of its own
- K221847: Ni2 Implant System (2024), 0 descendants of its own

## Indications for use
The S-Plant Dental 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 S-Plant Dental Implants (Ø3.4, 3.6, 3.8, 4.2, 4.7, 5.2 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 S-Plant Dental 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. Dual abutments are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Healing abutments are used to make a natural soft tissue shape before setting up prosthetics and removing cover screw after osseointegration. Cover Screws are used to protect the internal portion of the implant, preventing soft tissue growth into the implant, facilitating provisional restorations when necessary, and enabling the transition to final restoration components once osseointegration is complete.

Source page: https://510kreport.com/device/K221866
Methodology: https://510kreport.com/methodology