# K233081: NUVENTUS NV.C™ Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Infinitum Eta, Ltd.
- Decided: Nov 15, 2024 after 416 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 K894595 (1990). 87 ancestors in all.
No later device cites it as a predicate yet.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142260: NobelActive, Nobel Biocare AB (2015) Summary page 5.

## Indications for use
NUVENTUS NV.C™ Dental Implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. NUVENTUS NV.C™ dental implants may be used for immediate, early or delayed implantation following the extraction or loss of natural teeth. The implants can be placed with immediate loading for single-tooth or multiple teeth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. NUVENTUS NV.C™ Dental Implants are compatible for use with the following prosthetic interfaces.

Source page: https://510kreport.com/device/K233081
Methodology: https://510kreport.com/methodology