# K242217: Surcam Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Surcam Medical Devices and Developments, Ltd.
- Decided: Jan 29, 2025 after 184 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: 2 generations back to K163385 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 8.

## Indications for use
The Surcam 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 C Type and S Type 3.3mm diameter implants are indicated for use with only straight abutments. Temporary cylinders must be used in a splinted restoration only and are not for single crown restorations.

Source page: https://510kreport.com/device/K242217
Methodology: https://510kreport.com/methodology