# K133510: Neodent Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Jj Industria E Comercio DE Materiais Dentarios SA
- Decided: Feb 24, 2014 after 102 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: 12 generations back to K960026 (1996). 117 ancestors in all.
123 later devices descend from it; 5 cite it directly.
0 of 241 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101207: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2010) Summary page 2.
- K101945: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2011) Summary page 2.
- K123022: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2013) Summary page 2.

## Most influential descendants
- K133592: Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua and Drive Smart Acqua, Titamax CM (2014), 109 descendants of its own
- K150367: Neodent Implant System (2015), 89 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K173908: DESS Dental Smart Solutions (2018), 51 descendants of its own
- K191986: DESS Dental Smart Solutions (2019), 38 descendants of its own

## 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. Multiple tooth applications may be rigidly splinted.

Source page: https://510kreport.com/device/K133510
Methodology: https://510kreport.com/methodology