Legal analysis of the information contained in dental plaster packs

Abstract

AIM: The aims of this study were: a) to verify if the instructions displayed on the packages and labels of dental plaster available for purchase in the city of Porto Alegre are in accordance with the Brazilian laws, and b) to analyze how information is available on packages and labels of dental plaster acquired by dentists. METHODS: For this study, it was used the method proposed by Silva et al. (2010) modified, according to which the information related to instructions for product use displayed on packages and labels, if present, provided by manufacturers and/or importers from each brand of plaster was reviewed: how to use, composition, price, expiration date, health risks and disposal instructions. The collected information was subsequently confronted with the requirements laid out in national legislation on trade of dental plaster. RESULTS: No product showed the price or the instructions for disposal. One brand showed no information of the package and another one showed only the composition of the product; this requirement was present in most products. The mode of use and the expiration date were present in almost all packages, except for two brands. Only two brands presented information on health risks, and yet unsatisfactory. CONCLUSIONS: The different brands and types of dental plaster analyzed presented some kind of violation of the provisions of the Brazilian legislation, most with missing or unsatisfactory information.

calcium sulfate; forensic dentistry; consumer advocacy; product packaging; dental materials

• ¹
  Silva RF, Ramos DIA, Pereira SDR, Daruge Jr E, Daruge E. Plaster models: forensic importance and guidance for archiving. Rev Assoc Paul Cir Dent. 2007; 61: 381-4.
• ²
  Silva RF, Prado MM, Freitas GC, Oliveira HCM, Portilho CDM, Daruge Jr E. Legal analysis of packs of limes Kerr Part 1: information about manufacturers, importers and product features. Rev Odontol UNESP. 2008; 37: 337-43.
• ³
  Brazil. Common law number 8,078 of September 11, 1990. Treats of consumer protection and other measures. Federal Official Gazette of Brazil, Legislative Power 1990; 1990 Sept 12; p.1 (col. 1).
• ⁴
  National Agency of Sanitary Surveillance. Resolution RDC. 56, of April 6th, 2001. Establishes the essential requirements for safety and efficacy applicable to health products, referred to in the Technical Regulation annexed to this resolution. Federal Official Gazette of Brazil 2001, 2001 Apr 6.
• ⁵
  National Agency of Sanitary Surveillance. User manual of Resolution RDC 185/2001- guidance on registration, enrollment, modification, maintenance and cancellation of registration of medical products. Brasília, DF, version updated in January 7th, 2005.
• ⁶
  Fleming PS, Marinho V,Johal A. Orthodontic measurements on digital study models compared with plaster models: a systematic review. Orthod Craniofac Res. 2011; 14: 1-16.
• ⁷
  Silva RF, Prado MM, Oliveira HCM, Portilho CDM, Daruge Jr E. Legal analysis of information about usage instructions present in packs of limes K-file. RSBO. 2010; 7: 200-7.
• ⁸
  National Agency of Sanitary Surveillance. Resolution RDC n. 260, of September 23, 2002. Treats of the health products subjected to enrollment provided in article 3 of Resolution RDC n. 185/01. Federal Official Gazette of Brazil, 2002, 2002 Oct 3.
• ⁹
  Brazil. Common law number 5,081 ofAugust 24, 1966 Regulates the practice of dentistry. Federal Official Gazette of Brazil, Legislative Power 1966; p. 9843 (col. 1).
• ¹⁰
  Federal Council of Dentistry. Repeals Dental Code of Ethics approved by Resolution CFO-42/2003 and approves another instead. Resolution 118/ 2012, of May 11, 2012. Federal Official Gazette of Brazil 2012; 2012 May 11.
• ¹¹
  Brazil. Common law n. 10,406 of January 11, 2002. Establishing the Civil Code. Federal Official Gazette of Brazil, Legislative Power, 2002 Jan 11; p. 1 (col. 1).
• ¹²
  Pereira T, Santos Jr GC, Rubo JH, Ferreira PM, Valle AL. Plaster type IV: influences of manipulation techniques. Rev Fac Odontol. 2002; 10: 150-5.
• ¹³
  Algranti E, Chibante AMS. Pneumoconiosis in workers from dental laboratory. Rev Assoc Paul Cir Dent. 1993; 47: 969-72.
• ¹⁴
  Brazil. Law number 2,848 of 07 December 1940. Criminal Code. Federal Official Gazette of Brazil, Executive Power, 1940; 1940 Dec 31; p. 23911 (col. 2).
• ¹⁵
  National Agency of Sanitary Surveillance. Resolution RDC No. 306 of December 7, 2004 Treats of technical standards for waste management of health services Federal Official Gazette of Brazil, Brasília, DF, 2004 Dec 10.
• ¹⁶
  National Council of the Environment. Resolution No. 358 of 29 April 2005. Treats of the treatment and disposal of waste from health services and takes other measures Federal Official Gazette of Brazil, Brasília, DF, 2005 May 4.
• ¹⁷
  Fernandes MM, Francesquini Jr L, Daruge Jr E, Daruge E, Maduell TA, Pereira S. Knowledge of graduating students in dentistry about plan of waste management of health services - legal and ethical issues. RCO. 2009; 11: 13-6.
• ¹⁸
  Mutalik VS, Menon A, Jayalakshmi N, Kamath A, Raghu AR. Utility of cheiloscopy, rugoscopy, and dactyloscopy for human identification in a defined cohort. J Forensic Dent Sci. 2013; 5: 2-6.
• ¹⁹
  Santos KC, Fernandes CMS, Serra MC. Evaluation of a digital methodology for human identification using palatal rugoscopy. Braz J Oral Sci. 2011; 10: 199-203.
• ²⁰
  Verma AK, Kumar S, Bhattacharya S. Identification of a person with the help of bite brand analysis. J Oral Biol Craniofac Res. 2013; 3: 88-91.

Publication Dates

• Publication in this collection
  28 Oct 2013
• Date of issue
  Sept 2013

History

• Received
  15 May 2013
• Accepted
  11 Sept 2013