# K070935: T.B.R. Zirconnect

- Pathway: 510(k) (Abbreviated)
- Applicant: Sudimplant SA
- Decided: Nov 9, 2007 after 220 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: 6 generations back to K925765 (1993). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031475: Osseotite NT Certain Implants, Implant Innovations, Inc. (2003) Summary page 1.
- K050956: TBR Idea Conic/Conic, Sudimplant SA (2006) Summary page 1.

## Indications for use
The T.B.R.® Zirconnect endosseous dental implant is a device intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

Source page: https://510kreport.com/device/K070935
Methodology: https://510kreport.com/methodology