# K191191: Neodent Implant System - Temporary Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Decided: Dec 5, 2019 after 216 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: 12 generations back to K894595 (1990). 89 ancestors in all.
No later device cites it as a predicate yet.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163194: Neodent Implant System - GM Line, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2017) Summary page 4.

## Indications for use
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Neodent Implant System - Temporary Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.

Source page: https://510kreport.com/device/K191191
Methodology: https://510kreport.com/methodology