# K063622: Finecube Dental CT

- Pathway: 510(k) (Traditional)
- Applicant: The Yoshida Dental Mfg. Co., Ltd.
- Decided: Feb 8, 2007 after 65 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K973598 (1997). 6 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051980: DVT Scanner, Imaging Sciences Intl., Inc. (2005) Summary page 1.
- K030450: 3D Accu-I-Tomo Xyz Slice View Tomograph, J. Morita USA, Inc. (2003) Summary page 1.

## Most influential descendants
- K122199: PREXION3D Eclipse (2013), 6 descendants of its own
- K161881: PreXion3D Excelsior (2016), 2 descendants of its own
- K152489: ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray (2016), 2 descendants of its own
- K072574: Alphard Cone Beam CT, Model X178 (2007), 2 descendants of its own
- K210820: EAGLE EDGE AXR90 and AXR120 (2021), 1 descendant of its own

## Indications for use
FineCube is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.

Source page: https://510kreport.com/device/K063622
Methodology: https://510kreport.com/methodology