# K182615: Surgikor Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Surgikor, LLC
- Decided: Jul 8, 2019 after 290 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: 1 generation back to K163385 (2017). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163385: Cortex Dental Implant System, Cortex Dental Implants Industries, Ltd. (2017) Summary page 6.

## Most influential descendants
- K233271: OsseOne Dental Implant System (2025), 0 descendants of its own
- K242217: Surcam Dental Implant System (2025), 0 descendants of its own
- K240803: Surgikor Fixation One, Abutment Blanks and Abutments (2024), 0 descendants of its own

## Indications for use
Surgikor's Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The 7mm implants are intended to be used in the molar region.

Source page: https://510kreport.com/device/K182615
Methodology: https://510kreport.com/methodology