# K213677: Bonafix 2 Plus

- Pathway: 510(k) (Traditional)
- Applicant: Zentek Medical, LLC
- Decided: Dec 20, 2022 after 393 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: 12 generations back to K960026 (1996). 78 ancestors in all.
No later device cites it as a predicate yet.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191443: MSDI Dental Implants System, Medical Systems and Devices International, Ltd. (2020) Summary page 4.

## Indications for use
Bonafix 2 Plus Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Bonafix 2 Plus implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading.

Source page: https://510kreport.com/device/K213677
Methodology: https://510kreport.com/methodology