A matéria-prima utilizada para a confecção das próteses, não oferece nenhum tipo de risco à saúde, possuindo certificados de órgãos de saúde reconhecidos internacionalmente.
EUROPEAN UNION
This product is in compliance with the EU-Directives
90/128 of 23 December 1990, 92/99 of 14 May 1992
93/9 of 15 March 1993, 95/3 of February 1995,
98/11 of 5 Mach 1996, 99/91 of 23 November 1999
and 01/62 of 9 August 2001 for the monomers whit it
contains. This product does not contain additives.
Requirements:
Global migration limit (OML) 60mg/6dm3
Restriction=none.
USA FDA
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[Cite: 21 CFR177.1500]
[Page 263-269]
[Title 21FOOD AND DRUGS]
CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT
OF HEALTH AND HUMAN SERVICES (CONTINUED)
PART 177 - INDIRECT FOOD ADDITIVES: POLYMERS - Table of Contentes
Subpart BSubstances for Use as Basic Components of Single and
Pepeated Use Food Contact Surfaces.
[42 FR 14572, Mar. 15, 1977]
Editorial Note: For Federal Register citations affecting
Sect. 177.1500, see the List of CFR Sections Affected, which appears in
the Finding Aids section of printed volume and on GPO Access.