# K051715: Starpacs Dental

- Pathway: 510(k) (Traditional)
- Applicant: Infinitt Co., Ltd.
- Decided: Aug 2, 2005 after 36 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K010259 (2001). 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)
- K031013: Infintt CO., LTD. Starpacs System, Infinitt Company (2003) Summary page 1.
- K041078: Surgplan and Panplan, Imaging Sciences Intl., Inc. (2004) Summary page 1.

## Indications for use
StarPACS Dental TM device is a software package that scans (using direct digital capture using a solid state sensor) and stores those images. Additionally, the software has the ability to import DICOM images from volumetric data sets for visualization, analysis and reporting. The software allows the practitioner to perform surgical demonstrations for dental implant planning, cephlometric analysis, measurements and bone graft visualizations. The purpose of the software is to provide the doctor with a convenient method for visualization of these multiple imaging modalities, facilitates communication between multiple practitioners and to demonstrate treatment plan for the patient. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.

Source page: https://510kreport.com/device/K051715
Methodology: https://510kreport.com/methodology