# K243834: NobelZygoma TiUltra Implant system

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Aug 25, 2025 after 255 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: 5 generations back to K925771 (1993). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152093: NobelZygoma 45°, Nobel Biocare AB (2016) Summary page 6.
- K050641: Zygoma Tiunite, Nobel Biocare USA, LLC (2005) Summary page 6.
- K052885: Zygoma 17 Abutment Multi-Unit RP 2MM, Model 29314; Zygoma 17 Abutment Multi-Unit RP 3MM, Model 29315, Nobel Biocare USA, LLC (2005) Summary page 6.
- K161598: NobelZygoma 0°, Nobel Biocare AB (2017) Summary page 6.

## Indications for use
NobelZygoma TiUltra implants The NobelZygoma TiUltra implants are endosseous dental implants intended to be surgically placed in the zygomatic bone to support a dental prosthesis in the upper arch, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Multi-Unite Abutment Xeal Zygoma The Multi-unit Abutments Xeal Zygoma are indicated to support the placement of multiple unit, screw-retained prosthetic restorations in the maxilla including full arch dentures. NobelZygoma Multi-Unite Abutment Xeal Zygoma Screws The NobelZygoma Multi-Unit Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.

Source page: https://510kreport.com/device/K243834
Methodology: https://510kreport.com/methodology