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SILVA, Rhonan Ferreira da et al. Legal analysis of the instructions for use information in the K-Files packages. RSBO (Online) [online]. 2010, vol.7, n.2, pp. 200-207. ISSN 1984-5685.

INTRODUCTION: Anvisa classifies endodontic files as medical products and, therefore, all commercial trademarks sold in Brazil must have an adequate registration. To achieve this registration, several information on the product should be available to consumers (dentists) in order to allow its proper use and to avoid possible accidents. OBJECTIVE: To examine whether the information set forth in endodontic K-Files packages, labels and instructions for use are in accordance with current legislation, especially those established by Anvisa and the Consumer's Defense Code (CDC). MATERIAL AND METHODS: 29 retail dental centers were visited and 11 samples of different commercial trademarks of K-Files first series (15-40) were obtained, and the information available on them was submitted to an analysis based on legal orders. RESULTS: In all trademarks, there was no information available on how to use the product and on the means of storing the files before/after use. Only SybronEndo® trademark warned about the risks of using the files and reported criteria of number of use and disposal. Only Mani® trademark adequately informed on how to sterilize. CONCLUSION: It was verified that certain rules established by Anvisa and CDC are being disregarded concerning the display of certain necessary and required information that should be included on labels, instructions for use or K-Files commercial packages. Considering the large amount of information that must be available for the proper use of endodontic files, it is important that they are displayed preferably by means of instructions for use in the commercial package to be acquired by dentists.

Palavras-chave : consumer advocacy; dental instruments; Legal Dentistry.

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