# K260006: INOSS System

- Pathway: 510(k) (Traditional)
- Applicant: Inosys, Inc.
- Decided: Jun 17, 2026 after 166 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: 4 generations back to K041368 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170608: UF (II) Implant System, Dio Corporation (2018) Summary page 5.

## Indications for use
INOSS System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single-units' prosthetic attachment to restore a patient's chewing function. INOSS System 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.

Source page: https://510kreport.com/device/K260006
Methodology: https://510kreport.com/methodology