# K181869: On1 Universal Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Dec 12, 2018 after 153 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: 2 generations back to K132746 (2014). 2 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 9 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 4.

## Most influential descendants
- K202344: TiUltra Implants and Xeal Abutments (2020), 4 descendants of its own
- K211109: N1 TiUltra TCC Implant System (2021), 2 descendants of its own
- K220048: NobelProcera Zirconia N1 Base (2022), 1 descendant of its own
- 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
- K252197: Nobel Biocare S Series Implants (2026), 0 descendants of its own

## Indications for use
The On1™ device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The On1 Universal Abutments consist of three major parts. Specifically, the On1 Base, the On1 Universal Abutment, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

Source page: https://510kreport.com/device/K181869
Methodology: https://510kreport.com/methodology