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Subject Formaldehyde In Dental Implants

A European biomedical company was working on developing a new polymer based material to be potentially used for dental fillings. The company was in the process of applying for FDA approval in the US for which EMSL was hired to assist. Concern was raised that one of their polymer binders would potentially degrade and release formaldehyde. EMSL performed a careful formaldehyde release profile in an aqueous environment simulating the human mouth. Formaldehyde was in fact found to be released from the implants within the first month. To our knowledge, this product did not make it to US markets.

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