# K240202: Conical Platform Dental Implants System

- Pathway: 510(k) (Traditional)
- Applicant: Noris Medical, Ltd.
- Decided: Jun 6, 2024 after 133 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 5.

## Indications for use
Noris Medical Ltd. Conical Platform Dental Implants System id intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. Noris Medical Ltd. Conical platform Dental Implants diameter 3.25 are intended to replace lateral incisor in Maxilla and/or a central or lateral incisor in the mandible 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 impants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K240202
Methodology: https://510kreport.com/methodology