# K182293: OsseOne Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Synoross Dba Osseone
- Decided: Feb 15, 2019 after 175 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: 9 generations back to K894595 (1990). 23 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170372: SpiralTech Dental Implant System, Spiraltech Superior Dental Implants, Inc. (2017) Summary page 5.

## Most influential descendants
- K240837: TOV Dental Implant System (2024), 4 descendants of its own
- K250872: Bioline Dental Implant System (2025), 0 descendants of its own
- K233271: OsseOne Dental Implant System (2025), 0 descendants of its own
- K250176: DAND Dental Implant System (2025), 0 descendants of its own
- K243094: Quickdent Dental Implant System (2024), 0 descendants of its own

## Indications for use
OsseOne Dental 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 patients esthetics and chewing function. OsseOne implants are intended for single or multiple unit restorations on splinted or non-splinted applications. OsseoPlus and OsseoLock 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. OsseoLock 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another.

Source page: https://510kreport.com/device/K182293
Methodology: https://510kreport.com/methodology