# K193234: NUVO IF Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
- Decided: Jun 18, 2020 after 206 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: 9 generations back to K894595 (1990). 51 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 58 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 5.

## Most influential descendants
- K203309: NUVO CF Implant System (2021), 5 descendants of its own
- K233857: Neodent Implant System – Custom Abutments (2024), 2 descendants of its own
- K250614: Neodent Implant System - Custom Abutments (2025), 1 descendant of its own
- K220251: Neodent Implant System - GM Narrow Implant System (2022), 1 descendant of its own
- K260460: Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue (2026), 0 descendants of its own

## Indications for use
Indications for Use for NUVO IF Implants and conventional abutments: The NUVO IF Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order 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. The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure for up to 6 months. The Attachment Equator and Attachment Removable Prosthesis abutments are indicated for the attachment of full or partial dentures to NUVO implants. Indications for Use for Rotational and Anti-rotational Titanium Bases abutments: Titanium Base Abutment is a titanium base placed onto 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 or screw-retained single or multi-unit restorations or screw-retained single restorations. All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. The Rotational Titanium Base is indicated for cement or screw-retained multi-unit restorations. Indications for Use for CARES® Abutment IF: The CARES® Abutment is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations (copings or crowns). It is indicated for screw-retained or cement-retained single restorations. All digitally designed abutments for use with the CARES® Abutment are intended to be sent to Straumann for manufacturing at a validated milling center.

Source page: https://510kreport.com/device/K193234
Methodology: https://510kreport.com/methodology