# K192229: Neodent Implant System- GM Titanium Base for Bridge

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Decided: Dec 19, 2019 after 125 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: 13 generations back to K894595 (1990). 90 ancestors in all.
No later device cites it as a predicate yet.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180536: Neodent Implant System – GM Line, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2018) Summary page 4.

## Indications for use
Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations or screw-retained single restorations. All digitally designed copings and/or crowns to be used with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. The GM Titanium Base for Bridge is indicated for cement or screw-retained multi-unit restorations.

Source page: https://510kreport.com/device/K192229
Methodology: https://510kreport.com/methodology