# K150182: Neodent Implant System- CM Drive Implants

- Pathway: 510(k) (Special)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S
- Decided: Apr 23, 2015 after 86 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: 14 generations back to K960026 (1996). 119 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123022: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2013) Summary page 4.
- K133592: Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua and Drive Smart Acqua, Titamax CM, Neodent USA, Inc. (2014) Summary page 4.

## Most influential descendants
- K173961: Straumann BLX Implant System (2018), 15 descendants of its own
- K181703: Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments (2018), 5 descendants of its own
- K200586: Straumann TLX Implant System (2020), 4 descendants of its own
- K192401: Straumann Screw-Retained Abutments (2020), 2 descendants of its own
- K221315: UNIdental Symphony Implant System (2023), 1 descendant 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.

Source page: https://510kreport.com/device/K150182
Methodology: https://510kreport.com/methodology