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My Med Kft Vendel utca 11 - 1096 - Budapest - Hungary

p: +36 1 613 0045 | f: +36 1 794 5199

www.my-med.eu | info@my-med.eu

TECHNICAL SHEET

DESCRIPTION OF THE PRODUCT

Dental bleacher

COMMERCIAL DENOMINATION

MY WHITE

MY MED KFT Address: Vendel utca 11, 1096 Budapest – HUNGARY URL: http://www.my-white.eu E-Mail: info@mymed.hu/ info@my-med.eu / info@my-white.eu Tel.: +36 1 613 0045 Fax: +36 1 794 5199 VAT Number: HU 25708956

CODE My WHITE Evolution 1 - MYW001

My WHITE Evolution 4 - MYW004

CND Q010199

NSIS – N. REPORT 1547852

REGISTRATION CLASS

Class I - Non Sterile Medical Device Directive 93/42/CEE (D.L. 46/97 and successive modifications) Rule number 5

CE MARK The application of the CE mark is responsibility of the manufacturer who must complete a technical dossier containing the information required by the Medical Device Directive 93/42/EEC, Annex VII and notify the Ministry of Health the marketing of this device and compile a Declaration of Conformity.

SCOPE OF USEMy White Evolution is used to whiten a single tooth or more teeth with discolouration or devitalisation. Dental discromy may have been caused by: medicines, fluorosis, food-related spots and ageing.

RANGE

My White Evolution 1 - professional whitening kit contains: • 1 vial with 4ml of 38% hydrogen peroxide (My White Activator). • 1 jar with 1.6g powder (My White Base). • 1 spatula. • 1 Card patient. • Instructions for Use. My White Evolution 4 - professional whitening kit contains: • 4 vials with 4ml of 38% hydrogen peroxide (My White Activator). • 4 jars with 1.6g powder (My White Base). • 1 syringe with 3.5g Liquid Dam (My White Mask). • 4 metal tips. • 4 spatulas. • 4 patient card patient. • Instructions for Use

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My Med Kft Vendel utca 11 - 1096 - Budapest - Hungary

p: +36 1 613 0045 | f: +36 1 794 5199

www.my-med.eu | info@my-med.eu

RAW MATERIALS

Powder: - Silica gel - Carbopol - Eosina Y

Liquid: - Hydrogen Peroxide 38%

BIOCOMPATIBILITY

The product is intended to come into contact with the teeth. It may cause irritation to the patient. Before treatment the dentist should inform the patient about possible side effects. The treatment is temporary.

STERILITYNon Sterile. Not intend to be sterile before use.

EXPIRATIONMY MED KFT guarantees that if the product is stored as indicated on the label and/or as indicated on the package leaflet, it will have a useful life of 2 years from the date of production. The expiry date is on the label.

INSTRUCTION OF USE

a. Open the jar of My White Base. b. Cut with a scissor the point of the My White Activator vial and pour its content into the My White Base jar. c. Mix with the spatula until obtaining a soft viscosity gel. The gel will have a bright orange color.

For more information, read the Instructions of Use.

WARNINGS

• Hydrogen peroxide present in the kit is corrosive. ALWAYS USE PROTECTIVE GLASS, MASK AND GLOVES. • Avoid the gel contact with the skin and with the oral mucosa; in case of skin or oral mucosa contact, rinse abundantly with water. Consult a doctor if irritation persists. • In case of eye contact with the gel, rinse with plenty of water for at least 15 minutes and consult your doctor immediately. • In case of gel ingestion, drink plenty of water and consult a doctor. • In case of powder inhalation, breath in an open and well-ventilated area. If the breathing problem persists, consult a doctor. • Make the complete bleaching treatment for a single patient up to 2 times in one year. • The doctor must verify the integrity of the package before using the product. • Dispose of packaging according to local government regulations.  • Do not use the product for any purpose other than those that have been projected. • Store the product at a temperature between 5°C and 25°C (41°F-77°F) in a cool, dry, and ventilated place. Keep away from heat and light sources. • Keep out of reach of children.

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My Med Kft Vendel utca 11 - 1096 - Budapest - Hungary

p: +36 1 613 0045 | f: +36 1 794 5199

www.my-med.eu | info@my-med.eu

CONTRAINDICATIONS

Do not use the product in the following cases: • pregnant or lactating patients. • patients under 18 years of age. • patients with gingival disease, allergic to any of the components of the product, with the root exposed, with untreated primary and secondary caries, with crowns and bridges with marginal cracks.

There might be a temporary sensitization of the oral mucosa or the teeth; These symptoms usually disappear when the treatment is terminated or interrupted in a short time.

TRANSPORT Do not transport uncovered

STORAGEStore the product at a temperature between 5°C and 25°C (41°F - 77°F) in a cool, dry and ventilated place. Keep away from heat and light sources.

PACKAGINGThe product packaging was carried out considering the terminology, the information and the symbols requested in EN 1041 and EN 980 rules.

DISPOSALThis product disposal should be in compliance with applicable environmental and separate waste local regulations.

APPLICABLE LAWS

DIRECTIVE 93/42/EEC of 14 June 1993 and successive modifications (as amended by Dir. 2007/47/EC) - concerning medical devices. UNI EN ISO 9001:2015. Quality Management System - Requirements. UNI CEI EN ISO 13485:2012. Medical Devices - Quality Management System - Requirement for Regulatory Purposes. UNI CEI EN ISO 14971:2012. Medical Devices - Application of the Risk Management to Medical Devices. UNI CEI EN 980:2009. Symbols to be used on medical device labels. UNI CEI EN ISO 15223-1:2012. Symbols to be used in medical device labels, in labelling and in the information to be provided - Part 1: General requirements (not yet harmonised). UNI CEI EN 1041:2013. Information provided by the manufacturer with the Medical Devices. MEDDEV. 2.7.1 Rev. 4 of June 2016 - Guidelines on Medical Devices, Clinical Evaluation: a Guide for Manufacturers and Notified Bodies. MEDDEV 2.4/1 Rev. 9 of June 2010 - Guidelines Relating to the Application of Council Directive 93/42/EEC on Medical Devices. MEDDEV 2.12-1 Rev. 8 of January 2013 - Guidelines on a medical devices vigilance system NB-MED/2.12/Rec1 - Post-Marketing Surveillance (PMS) post market/production MINISTRY DECREE November 15, 2005 - Approval of accident-reporting or non-response reporting templates involving medical devices and in-vitro diagnostic medical devices.

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