# K240803: Surgikor Fixation One, Abutment Blanks and Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Surgikor, LLC
- Decided: Sep 12, 2024 after 171 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: 19 generations back to K960026 (1996). 324 ancestors in all.
No later device cites it as a predicate yet.
0 of 325 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182615: Surgikor Dental Implant System, Surgikor, LLC (2019) Summary page 5.
- K202026: Blue Sky Bio CAD-CAM Abutments, Blue Sky Bio, LLC (2020) Summary page 5.

## 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. Surgikor Abutment Blanks and Abutments are intended to be used in conjunction with Surgikor endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. All digitally designed abutments for use with Surgikor Abutment Blanks are intended to be sent to a Surgikor validated milling center for manufacture.

Source page: https://510kreport.com/device/K240803
Methodology: https://510kreport.com/methodology