CURASEPT BIOSMALTO MOUTHWASH CARIES ABRASION & EROSION

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mouthwash and pack Curasept Biosmalto Caries Abrasion Erosion

CURASEPT BIOSMALTO MOUTHWASH CARIES ABRASION & EROSION

Partially substituted hydroxyapatite conjugated with Chitosan + Fluorohydroxyapatite. Alcohol-free, SLS/SLES-free. Contains 250 ppm F-

Format: 300 ml

The Biosmalto Carie Abrasione & Erosione line effectively remineralizes enamel and dentin, prevents cavities, inhibits plaque growth, protects against acid erosion and abrasion, and prevents sensitivity when combined with mechanical oral hygiene and a low-sugar diet.

Remineralizing action.

Use:

Daily use. Mouthwash for adults and children over 7 years old. Shake well before use.
Rinse with 10 ml of product for about one minute, at least twice a day, in combination with Biosmalto Carie Abrasione Erosione toothpaste.

In case of severe demineralization, it is recommended to use the mousse, and for better results, a synergistic and prolonged use of mouthwash, toothpaste, and toothbrush from the line is advised.

This is a medical device . Carefully read the warnings or instructions for use.

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Quality Policy

The Quality for CURASEPT S.p.A. is an essential condition to put itself successfully on the market, considering its characteristics and evolution.

The development of the Company and its profit are insured by the continuous search for quality towards excellence through the continuous improvement of its processes and the search for partners with quality systems adapted to our standards.

The Company aims to increase the customer satisfaction through the application of its Quality Management System, including the processes to improve the system and to ensure the compliance with the customer and applicable regulatory requirements.

For this purpose, the Company performs specific risks and opportunities assessment activities, connected to the context, stakeholders and related objectives, in order to identify the areas of system improvements and to define the appropriate actions for the risk control and mitigation and strengthening of its Quality System.

The starting point for the implementation of this policy is the pursuit of the following objectives:

Define and implement a Quality Management System according to 9001:2015+A1:2024 e UNI CEI EN ISO 13485:2021 regulation, as Manufacturer of Medical Devices;
Define and implement a system of procedures and operating instructions in harmony with the Directive 93/42/CEE, the Regulation (UE) 2017/745 and the Regulation (UE) 2023/607 for the applicable parts and subsequent changes and integrations, which satisfy the essential requirements set out in Annex I;
Define and implement a system of procedures in harmony with the Directive 2010/84, the Regulation 1235/2010, the Implementation Regulation n. 520/2012 and in accordance with the objectives of “module I – “Good Vigilance Practices” (GVP);
Establish and formalize the business organizational structure with the subdivision into areas of competences;
Clarify roles and responsibilities of business functions;
Define strategies and objectives and assign human and material resources for their achievement;
Define accurately business processes and related performance factors;
Ensure compliance with qualitative, quantitative and temporal requirements;
Constantly monitor the level of adequacy of the system with reference to regulations and laws;
Promote initiatives in order to improve the process of motivational and professional growth of human resources, considered as critical resources for future business developments;
Ensure the commitment to the satisfaction of requirements and the maintenance of effectiveness of the Quality Management System.

These objectives can be realized thanks to the involvement of the whole Company personnel.

In particular, the Managers of each Function provide their contribution so that the suggested improvements can be proposed to the General Direction, so that the Quality Policy can be a priority element in the choice of business qualitative and organizational strategies.

The involvement of the whole personnel in the improvement of internal and external processes should be aimed at reducing non-compliance and internal and external costs of non-quality; for this reason all employees should feel themselves committed in pursuing this policy.

Training courses, for all business levels, are promoted and planned by the General Direction in order to keep the personnel constantly up to date on the improvements performed for the processes.

The Quality Manual, which is distributed via the SistemaQualità to all process managers and the General Director, should represent a work tool for all Managers and their personnel for the implementation of the Quality Policy.

April 2025

General Direction