Entities: Pyoor Smile LTD (Israel) | ARC Ortho Dental S.L. (Spain)

1. Introduction and Scope

This Privacy Policy describes how Pyoor Smile LTD (Israel) and ARC Ortho Dental S.L. (Spain) (collectively, the "Company", "we", or "us") collect, use, and protect personal and sensitive medical data. This policy applies to all users of our Physician Portal and the medical data submitted for the production of custom-made clear aligners .

 

2. Identity and Contact Details of the Data Controllers

The entities responsible for data processing in accordance with the General Data Protection Regulation (GDPR) and the Israeli Privacy Protection Law are:

• For Israel: Pyoor Smile LTD, Avner Ben Ner 8, Ness Ziona, Israel.
   

• For Europe: ARC Ortho Dental S.L., Merla 15, Sant Cugat dell Valles, Spain.
   

• Contact Email: info@arc-aligners.com
   

3. Categories of Data Collected

We collect and process the following categories of data:

• Physician Data: Full name, medical license number, clinic address, contact details, and payment information .
   

• Patient Medical Data: Digital dental scans (STL files), clinical photographs, X-rays, and treatment instructions submitted by the physician.
   

• Technical Data: IP address, browser type, and usage logs of the Portal .
   

4. Legal Basis for Processing

Our processing is based on the following legal grounds:

• Contractual Necessity: To provide the portal services and fulfill orders for custom-made devices (Art. 6(1)(b) GDPR) .
   

• Explicit Consent: For the processing of sensitive medical/health data (Art. 9(2)(a) GDPR) .
   

• Legal Obligation: Compliance with medical device traceability regulations (MDR/RD 192/2023) .
   

• Legitimate Interests: To ensure technical security and optimize portal performance (Art. 6(1)(f) GDPR) .
   

5. Anonymization and Data Protection Measures

To ensure the highest level of privacy for patients, the Company implements the following measures:

• Unique Case ID: Patient names are not printed on physical packaging or aligners. All identification throughout the production and logistics chain is conducted via a Unique Case ID only .
   

• Data Minimization: We only collect data strictly necessary for treatment planning and manufacturing .
   

• Encryption: All data transmitted via the Portal is encrypted and stored using industry-standard security protocols.
   

6. International Data Transfers

To facilitate the manufacturing of custom-made aligners, personal and medical data is transferred across borders as follows:

• From the Physician to the Company’s secure servers.

• To authorized International Planning and Production Sites for the purposes of treatment simulation, 3D modeling, and physical manufacturing . All international transfers are conducted in compliance with applicable data protection laws, including the use of Standard Contractual Clauses (SCCs) to ensure a level of protection equivalent to GDPR standards .
   

7. Data Storage and Retention

• Active Records: Medical data is stored for as long as necessary to fulfill the treatment and as required by medical device retention laws.
   

• Future Production: We retain 3D data (STL files) specifically to allow for the future production of retainers or treatment refinements.
   

• Deletion: Data will be deleted or anonymized once the legal retention periods expire or when the data is no longer required for its original purpose .
   

8. Rights of the Data Subject

Under the GDPR and Israeli law, data subjects (Physicians and Patients) have the following rights:

• Right to Information: To know what data we hold and the purpose of processing .
   

• Right to Rectification: To correct inaccurate or incomplete data .
   

• Right to Erasure: To request deletion of data, subject to legal retention obligations .
   

• Right to Withdraw Consent: To withdraw consent for processing health data at any time.
   

9. Use of Cookies and Analytics

Our Portal uses technical cookies to ensure functionality (e.g., login sessions, language settings) . We may use pseudonymized analytics to improve the user experience and ensure system security .

 

10. Updates to this Policy

We reserve the right to update this Privacy Policy to reflect changes in our services or regulatory requirements . Physicians will be notified of material changes via the Portal.