RDA (RELATIVE DENTIN ABRASION)

ISO 11609 Annex B

CONFIRMED STANDARDS AND METHODS

THE STUDY IS CONDUCTED, PROVEN AND COMPLIANT WITH ISO 11609 STANDARDS:Purpose: To use acellular samples of human dentin as a test substrate to determine the RDA of Product: PRANOYA Toothpaste for Cosmetic Dentistry and Natural Teeth against the ISO 11609 reference index (Annex B).Conclusion:- The abrasivity of the PRANOYA toothpaste formulation evaluated in this study was well below the upper safe limit of ISO 11609.- PRANOYA toothpaste formulation has passed ISO 11609 safety requirements.At 2000 stokes it has a low RDA, at 4000 stokes (3rd standard and latest version) it has an RDA of 104 (ideally 100).

MICROBIOLOGICAL TEST

The study is accredited by RENAR and ILAC-MRA

CONFIRMED STANDARDS AND METHODS

CHALLENGE TEST

Accredited laboratory

CONFIRMED STANDARDS AND METHODS

PHYSICAL CHEMICAL TESTS

Accredited laboratory

CONFIRMED STANDARDS AND METHODS

PB-155 ed.I of 02.05.2012 - CONFORMABLEPB-234 ed. I of 03.10.2013r. - CONFORMABLEBrookfield DVIII ultra - CONFORMABLE

DERMATOLOGICAL COMPATIBILITY TEST

THE STUDY IS CARRIED OUT, PROVED AND IN ACCORDANCE WITH THE STANDARDS:Regulation of European Parliament of Council (EC) No. 1223/2009 of 30 November 2009 on cosmetic products.Cosmetics Europe - The Personal Care Association (previously COLIPA) Guidelines “Product TestGuidelines for the Assessment of Human Skin Compatibility 1997Cosmetics Europe - The Personal Care Association (previously COLIPA) Guidelines for the Evaluation of the Efficacy of Cosmetic Products 2008. The dermatological study was performed on a sample of 50 people of which 25 with a negative allergen history and 25 with a positive allergen history.Two assessments were made at 48 and 72 hours, respectively.The result of the study proved 0 (zero) allergenic reactions in all subjects tested.

STABILITY AND COMPATIBILITY IN VIEW OF DETERMINATION OF MINIMUM DURABILITY

THE STUDY IS CARRIED OUT, PROOF AND IN ACCORDANCE WITH THE STANDARDS:Regulation of European Parliament of Council (EC) No. 1223/2009 of 30 November 2009 on cosmetic products.“Guidelines on stability testing of cosmetic products, March 2004” (CTFA)Strictly tested with fluctuations 70 days.

Human Clinical Trials - UNDER DENTIST SUPERVISIONFor Cosmetic Dentistry and Natural Teeth

THE STUDY IS CARRIED OUT, PROVED AND IN ACCORDANCE WITH THE STANDARDS:Regulation of European Parliament of Council (EC) No. 1223/2009 of 30 November 2009 on cosmetic products.Cosmetics Europe - The Personal Care Association (previously COLIPA) Guidelines “Product TestGuidelines for the Assessment of Human Skin Compatibility 1997Cosmetics Europe - The Personal Care Association (previously COLIPA) Guidelines for the Evaluation of the Efficacy of Cosmetic Products 2008 The clinical study was performed over a period of 28 days with a sample of 20 people aged 21 to 67 years and multiple dental problems: yellow teeth, discoloration, caries, dental plaque, dental sensitivity, recent dental cosmetic work (prosthetic works: dental veneers and crowns)

Conclusions and results:

It was tested under supervision dentist ;The results of the tests concluded that the product is very good tolerated by all tested subjects, as a result there are no contraindications;Confirmed properties of the product following the clinical trial:

- Cleans teeth efficiently- Gently brush your teeth- Restores natural white and shine- Visibly removes dental plaque- Provides a feeling of cleanliness after using the product- Refreshes the breath- Helps maintain oral hygiene- Provides a feeling of freshness- Suitable for everyday use

SAFETY EVALUATION OF PRODUCT

THE STUDY IS CARRIED OUT, PROVED AND IN ACCORDANCE WITH THE STANDARDS:Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products ANNEX I

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