# K220048: NobelProcera Zirconia N1 Base

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Services AG
- Decided: Jul 29, 2022 after 204 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 K894595 (1990). 99 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161655: On1 Concept, Nobel Biocare AB (2017) Summary page 5.
- K211109: N1 TiUltra TCC Implant System, Nobel Biocare Services AG (2021) Summary page 5.

## Most influential descendants
- K253999: Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw (2026), 0 descendants of its own

## Indications for use
NobelProcera® Zirconia Abutment / Implant Crown N1™ Base: The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base is a patient-matched CAD/CAM prosthetic component directly connected to an endosseous dental implant abutment with the Prosthetic Screw and is indicated for use as an aid in prosthetic rehabilitation. Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base: The Prosthetic Screw is to be directly connected to the dental abutment or crown, indicated for use as an aid in prosthetic rehabilitation.

Source page: https://510kreport.com/device/K220048
Methodology: https://510kreport.com/methodology