# K203542: Neodent Implant System - Mini Abutment 60°

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Decided: Aug 2, 2021 after 242 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
Longest line of descent: 15 generations back to K960026 (1996). 133 ancestors in all.
No later device cites it as a predicate yet.
0 of 134 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190718: Zygomatic Implants, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2019) Summary page 4.

## Indications for use
The Mini Conical Abutments are indicated for use with Zygomatic Implants, in cases of severe jaw resorption, in order to restore patient aesthetics and chewing function. It may be used with single-stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K203542
Methodology: https://510kreport.com/methodology