Author: United States Food and Drug Administration
Source: Federal Register
Year: 1987
Comment:
When the Final Rule of the FDA on Classifications of Dental Devices was published in the Federal Register on August 12, 1987, there was no mention or classification of dental amalgam as a dental device. Instead, the individual components of amalgam were approved and classified: Mercury was placed in Class I (less risk, no proof of safety needed), and amalgam alloy (the material mixed with the mercury to form amalgam) was placed in Class II (more risk, no proof of safety needed).
Abstract / Excerpt:
Not available.
Citation:
United States Food and Drug Administration. 52 FR 30082. Federal Register. August 12, 1987.