Disclaimer - DentalMonitoring

DentalMonitoring disclaimer – applicable to SaMD version

The following indications can be used for the remote monitoring of dental treatments, orthodontic
treatments, oral health, and treatment progress:

closure of all anterior spaces,
closure of extraction space,
black triangle,
canine class value in millimeters (3D Monitoring only),
overjet value in millimeters (2D Monitoring and 3D Monitoring),
midline deviation value in millimeters (2D Monitoring and 3D Monitoring),
overbite/open bite value in millimeters (2D Monitoring and 3D Monitoring),
for aligner treatments:
- tracking (seat/unseat),
- attachment loss,
- button loss
for braces:
- bracket debonding,
- tie loss,
- self-ligating clips,
- passive archwire and auxiliaries (2D Monitoring and 3D Monitoring),
for thermoformed retainers:
- tracking (seat/unseat).

Only for use on all permanent teeth excluding third molars and lingual surfaces. Mandatory use of
DentalMonitoring’s proprietary hardware products.

Smart STL feature: The provided STL files are representative of the patient’s dentition and treatment
progress. These files are approved as a medical device. Only for use on permanent teeth. Mandatory use
of DentalMonitoring’s proprietary hardware products.

The above are approved as a medical device in the following territories:

United States
EU countries : Austria, Belgium, Czechia, Finland, France, Germany, Ireland, Italy, Luxembourg,
Malta, Netherlands, Poland, Portugal, Slovakia, Spain, Sweden
non-EU countries: Australia, Hong Kong, Liechtenstein, Monaco, New Zealand,Switzerland, United Kingdom

Across territories, results of all other product features are considered for Research Use Only and are
provided for information purposes only. Any resulting orthodontic treatment decision is the sole
responsibility of the practitioner. Only for use on permanent teeth. Mandatory use of DentalMonitoring’s
proprietary hardware products