# K233271: OsseOne Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Synoross Dba Osseone
- Decided: May 8, 2025 after 587 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: 11 generations back to K894595 (1990). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182293: OsseOne Dental Implant System, Synoross Dba Osseone (2019) Summary page 5.
- K240837: TOV Dental Implant System, Rdj Tov Implant, Ltd. (2024). Cleared while this submission was under review Summary page 8.
- K182615: Surgikor Dental Implant System, Surgikor, LLC (2019) Summary page 8.

## Indications for use
The OsseOne Dental Implant System implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient’s esthetics and chewing function. OsseOne Dental implants are intended for single or multiple unit restorations on splinted or non-splinted applications. OsseOne Dental implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.

Source page: https://510kreport.com/device/K233271
Methodology: https://510kreport.com/methodology