# K141777: Neodent Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S
- Decided: Jul 20, 2015 after 383 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: 13 generations back to K960026 (1996). 131 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070182: Zygoma Implant (Immediate Function), Nobel Biocare AB (2007) Summary page 5.
- K133510: Neodent Implant System, Jj Industria E Comercio DE Materiais Dentarios SA (2014) Summary page 6.
- K123022: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2013) Summary page 6.

## Most influential descendants
- K190718: Zygomatic Implants (2019), 2 descendants of its own
- K173343: Zygomatic Implant System (2018), 2 descendants of its own
- K192651: ZAGA Zygomatic System (2020), 1 descendant of its own
- K153064: Blue Sky Bio Zygomatic Implant System (2016), 1 descendant of its own
- K232099: Neodent Implant System - GM Zygomatic Implant System (2023), 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/K141777
Methodology: https://510kreport.com/methodology