# K150367: Neodent Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S
- Decided: Jul 13, 2015 after 151 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: 14 generations back to K960026 (1996). 238 ancestors in all.
89 later devices descend from it; 3 cite it directly.
0 of 328 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST, Institut Straumann AG (2012) Summary page 6.
- K052272: Straumann Computer Aided Restoration Service, Straumann USA (2006) Summary page 6.
- K133421: Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal Screw, Straumann USA, LLC (2014) Summary page 6.
- 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 5.
- K123022: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2013) Summary page 5.
- K101945: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2011) Summary page 5.

## Most influential descendants
- 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
- K183518: Preat Abutments (2019), 22 descendants of its own
- K212628: DESS Dental Smart Solutions (2022), 20 descendants of its own

## 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. PreFace Abutment is a titanium abutment to be used in fabricating a full custom abutment and placed onto Neodent dental implants to provide support for customized prosthetic restorations. PreFace Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations.

Source page: https://510kreport.com/device/K150367
Methodology: https://510kreport.com/methodology