6. Not a medical device

6.1What LatinoSoft is

LatinoSoft is practice management software. It records what the practitioner enters, schedules appointments, produces invoices and claims, and sends reminders. It is an administrative tool for the practice.

6.2What LatinoSoft is not

1. LatinoSoft makes no diagnosis, recommends no treatment, calculates no dosage and takes no clinical decision. It is not intended for a medical purpose within the meaning of art. 2(1) of Regulation (EU) 2017/745 (MDR).
2. Stardent B.V. has not registered LatinoSoft as a medical device and does not offer it as one. There is no CE marking as a medical device and none is claimed.
3. All clinical decisions remain with the practitioner. What the software shows — a treatment plan, a periodontal chart, a medication list, a medical history, a body map — is a rendering of what the practice itself entered, not an assessment by the software.

6.3What this means for the practice

1. The practice does not use the software as the source of a clinical decision without its own assessment of the underlying data.
2. If the practice finds that a module is nevertheless being used to determine a clinical outcome, it reports that through dentalsoft@godentalplace.com, so that Stardent B.V. can assess whether the intended use must be adjusted.