# K210039: CORE1 Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Cybermed, Inc.
- Decided: Jan 7, 2022 after 366 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: 14 generations back to K894595 (1990). 98 ancestors in all.
No later device cites it as a predicate yet.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153639: OneQ-SL s-Clean Implant System, Dentis Co., Ltd. (2016) Summary page 4.

## Indications for use
CORE1 Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading. CORE1 Implant System 3.3mm diameter implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

Source page: https://510kreport.com/device/K210039
Methodology: https://510kreport.com/methodology