# K210852: Noris Medical Dental Implants System - Cortical

- Pathway: 510(k) (Traditional)
- Applicant: Noris Medical, Ltd.
- Decided: Jun 24, 2022 after 459 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: 16 generations back to K960026 (1996). 249 ancestors in all.
No later device cites it as a predicate yet.
0 of 250 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140440: Noris Medical Dental Implants System, Noris Medical, Ltd. (2014) Summary page 4.

## Indications for use
Noris Medical Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The procedure can be accomplished in a one-stage or two-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K210852
Methodology: https://510kreport.com/methodology