# K190718: Zygomatic Implants

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Decided: Jul 11, 2019 after 113 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: 14 generations back to K960026 (1996). 132 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141777: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2015) Summary page 4.
- (no number) Neodent Implant System – GM Line: named in the summary without a submission number
- (no number) NobelZygoma 0°: named in the summary without a submission number

## Most influential descendants
- K232099: Neodent Implant System - GM Zygomatic Implant System (2023), 0 descendants of its own
- K203542: Neodent Implant System - Mini Abutment 60° (2021), 0 descendants of its own

## Indications for use
Zygomatic Implants are indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Zygomatic Implants are recommended for the posterior (pre-molar/molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Zygomatic Implants may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K190718
Methodology: https://510kreport.com/methodology