# K161655: On1 Concept

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Feb 28, 2017 after 257 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: 1 generation back to K132746 (2014). 1 ancestor in all.
10 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132746: Nobelprocera Angulated Screw Channel Abutment Conical Connection, Nobel Biocare USA, LLC (2014) Summary page 4.

## Most influential descendants
- K181869: On1 Universal Abutment (2018), 6 descendants of its own
- K202344: TiUltra Implants and Xeal Abutments (2020), 4 descendants of its own
- K211109: N1 TiUltra TCC Implant System (2021), 2 descendants of its own
- K220253: Eco Abutment, Multiunit Abutment (2023), 1 descendant of its own
- K220048: NobelProcera Zirconia N1 Base (2022), 1 descendant 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.

Source page: https://510kreport.com/device/K161655
Methodology: https://510kreport.com/methodology