# K101945: Neodent Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S
- Decided: Jan 26, 2011 after 198 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: 8 generations back to K894595 (1990). 50 ancestors in all.
180 later devices descend from it; 14 cite it directly.
0 of 231 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003226: The Lifecore Stage-1 Single Stage RBM Dental Implant System, Lifecore Biomedical, Inc. (2001) Summary page 2.
- K032495: The Lifecore Stage-1 Angled Abutment System, Lifecore Biomedical, Inc. (2003) Summary page 2.
- K083805: Ankylos C/X Dental Implant System, Dentsply Intl., Inc. (2009) Summary page 2.
- K050406: Nobelspeedy Implants, Nobel Biocare AB (2005) Summary page 2.
- K031719: Esthetic Zirconia Abutment, Nobel Biocare AB (2003) Summary page 2.
- K033922: Modification to Iti Dental Implant System, Institut Straumann AG (2004) Summary page 2.
- K041295: RN Synocta Ucla Gold Abutment for the Straumann Dental Implant, Institut Straumann AG (2004) Summary page 2.
- K022859: Abutment and Prosthetic Accessories to the Iti Dental Implant System, Straumann USA (2002) Summary page 2.
- K053384: Fixature Microthread Osseospeed, a Component of the Astra Tech Implant System, Astra Tech, Inc. (2006) Summary page 2.
- K101207: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2010). Cleared while this submission was under review Summary page 2.

## Most influential descendants
- K123022: Neodent Implant System (2013), 127 descendants of its own
- K133510: Neodent Implant System (2014), 123 descendants of its own
- K133421: Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal Screw (2014), 115 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

## 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/K101945
Methodology: https://510kreport.com/methodology