# K050641: Zygoma Tiunite

- Pathway: 510(k) (Special)
- Applicant: Nobel Biocare USA, LLC
- Decided: Apr 7, 2005 after 24 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K070182: Zygoma Implant (Immediate Function) (2007), 19 descendants of its own
- K093562: Endosseous Dental Implant (2010), 10 descendants of its own
- K141777: Neodent Implant System (2015), 8 descendants of its own
- K151909: Noris Medical Zygomatic Dental Implant System (2016), 7 descendants of its own
- K152093: NobelZygoma 45° (2016), 3 descendants of its own

## Indications for use
Nobel Biocare's Zygoma TiUnite® is a titanium, endosseous implant with components intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth in order to restore patient esthetics and chewing function. Nobel Biocare's Zygoma TiUnite® includes endosseous implants, a cover screw, healing abutments, and muiti-unit abutments.

Source page: https://510kreport.com/device/K050641
Methodology: https://510kreport.com/methodology