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As an example of the outdatedness of the Special Controls guidance, FDA cites the HHS 1993 Scientific review to support the statement Dental amalgam has been demonstrated to be an effective restorative material that has benefits in terms of strength, marginal integrity, suitability for large occlusal surfaces, and durability. If there wasnt then, over thirty years later, there is more than sufficient evidence to refute this claim (See Appendix II)

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doi: 10.1038/s41586-020-03148-w 35 RathSSharmaRGuptaRAstTChanCDurhamTJet al