# K203309: NUVO CF Implant System

- Pathway: 510(k) (Traditional)
- Applicant: JJGC Indústria e Comércio de Materiais Dentários S.A.
- Decided: Jul 6, 2021 after 238 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: 10 generations back to K894595 (1990). 52 ancestors in all.
5 later devices descend from it; 3 cite 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)
- K193234: NUVO IF Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2020) Summary page 6.

## Most influential descendants
- 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
- K230104: Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL (2023), 0 descendants of its own

## Indications for use
Indications for Use for NUVO CF Implants: The 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. Indications for Use for NUVO CF Traditional Abutments: The 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. Indications for Use for Attachment Equator CF: The Attachment Equator CF 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 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 Attachment Equator abutments are indicated for the attachment of full or partial dentures to NUVO implants. Indications for Use for Attachment Removable Prosthesis CF: The Attachment Removable Prosthesis CF 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 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 Attachment Removable Prosthesis abutments are indicated for the attachment of full or partial dentures to Nuvo implants. Indications for Use for Temporary Abutments CF for Crown and for Bridge: The 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. Indications for Use for CF Titanium Base for Crown: CF Titanium Base for Crown is a titanium abutment placed onto dental implants to provide support for customized prosthetic restorations, as copings or crowns. It is indicated for single-unit restorations, cement-retained or screw-retained in aesthetic areas on implants installed in the maxilla or mandible. 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. Indications for Use for CF Titanium Base for Bridge: CF Titanium Base for Bridge is a titanium abutment placed onto dental implants to provide support for customized prosthetic restorations. The CF Titanium Base for Bridge is indicated for cement or screw-retained multi-unit 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. Indications for Use for Cares Abutment CF: The CARES® Abutment CF 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/K203309
Methodology: https://510kreport.com/methodology