# K251220: NUVENTUS NV.C™ Prosthetic Components

- Pathway: 510(k) (Traditional)
- Applicant: Infinitum Eta, Ltd.
- Decided: Jul 28, 2025 after 98 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: 17 generations back to K960026 (1996). 142 ancestors in all.
No later device cites it as a predicate yet.
0 of 143 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071370: Nobelactive Internal Connection Implant, Nobel Biocare AB (2007) Summary page 6.
- K220751: Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA, Institut Straumann AG (2022) Summary page 6.
- K132746: Nobelprocera Angulated Screw Channel Abutment Conical Connection, Nobel Biocare USA, LLC (2014) Summary page 6.
- K161416: Multi-unit Abutment Plus, Nobel Biocare AB (2017) Summary page 6.
- K113410: NNC Solid Abutment NNC Temporary Coping for Colid Abutment NNC Temporary Cap for Colid Abutment, Straumann USA (2012) Summary page 6.

## Indications for use
NUVENTUS NV.C™ healing components are indicated to be placed in fully or partially edentulous patients after implant placement. The healing components protect the inner configuration of the implant and form, maintain, and stabilize the soft tissue during the healing process. Healing components have a maximum duration of usage of 180 days. NUVENTUS NV.C™ temporary prosthetic components are indicated to be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must not be placed in occlusion. Temporary prosthetic components have a maximum duration of usage of 180 days. NUVENTUS NV.C™ Multi-unit Abutments are indicated to be placed into NUVENTUS NV.C™ dental implants to provide a support structure for the functional and esthetic oral rehabilitation of fully or partially edentulous patients with bridges or full-arch prostheses. NUVENTUS NV.C™ Multi-unit Final Coping is connected to the endosseous dental implant via multi-unit abutment and are indicated for use as an aid in prosthetic rehabilitations in fully or partially edentulous patients with bridges or full-arch prostheses.

Source page: https://510kreport.com/device/K251220
Methodology: https://510kreport.com/methodology