# K241462: LONGY Implant and LONGY-N Implant

- Pathway: 510(k) (Traditional)
- Applicant: Noris Medical, Ltd.
- Decided: Feb 11, 2025 after 264 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: 11 generations back to K925765 (1993). 73 ancestors in all.
No later device cites it as a predicate yet.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190958: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2019) Summary page 5.

## Indications for use
The Noris LONGY and LONGY-N implants are indicated for splinted restorations in the maxilla, utilizing a minimum of two implants to support fixed or removable prosthetic devices in patients with partially or fully edentulous upper jaws, and may be suitable for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The procedure can be accomplished in a one-stage or two-stage surgical operation.

Source page: https://510kreport.com/device/K241462
Methodology: https://510kreport.com/methodology