# K123022: Neodent Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S
- Decided: May 17, 2013 after 231 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: 11 generations back to K960026 (1996). 116 ancestors in all.
127 later devices descend from it; 9 cite it directly.
0 of 244 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101945: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2011) Summary page 2.
- K070601: Mini Drive-Lock Dental Implant System, Intra-Lock International (2007) Summary page 2.
- K080598: Mini Drive-Lock Dental Implant System Prosthetics, Intra-Lock International (2008) Summary page 2.
- K073343: Ace Surgical Secure-Mini Implant System, Model 09-270X-XX, Ace Surgical Supply Co., Inc. (2008) Summary page 2.
- K092594: Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OX, Ace Surgical Supply Co., Inc. (2009) Summary page 2.
- K081653: Mdi Mii One-Piece Implant, 2.9MM, Imtec Corp. (2008) Summary page 2.
- K092035: Bicon Implants with a 2.5MM Internal Connection, Bicon, LLC (2009) Summary page 2.
- K050712: 4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental Implant, Bicon, Inc. (2005) Summary page 2.
- K010185: 6.0 X 5.7MM Dental Implant, Bicon, Inc. (2002) Summary page 2.

## Most influential descendants
- K133510: Neodent Implant System (2014), 123 descendants of its own
- 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

## 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 ar twa-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Titamax WS implant is indicated far a delayed loading protocol. The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.

Source page: https://510kreport.com/device/K123022
Methodology: https://510kreport.com/methodology