# K232012: N1

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Nov 28, 2023 after 145 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000061 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051795: Nomad Dental X-Ray System, Aribex, Inc. (2005) Summary page 4.

## Indications for use
N1 is a dental portable X-ray imaging system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use N1 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.

Source page: https://510kreport.com/device/K232012
Methodology: https://510kreport.com/methodology