federal_register: 2017-25065

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2017-25065 Medical Devices; Exemption From Premarket Notification: Over-the-Counter Denture Repair Kits Notice The Food and Drug Administration (FDA or Agency) is announcing that it has received a petition requesting exemption from the premarket notification requirements for over-the-counter (OTC) denture repair kits. These devices consist of material, such as a resin monomer system of powder and liquid glues, which is intended to be applied permanently to a denture to mend cracks or breaks. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA). 2017-11-20 2017 11 https://www.federalregister.gov/documents/2017/11/20/2017-25065/medical-devices-exemption-from-premarket-notification-over-the-counter-denture-repair-kits https://www.govinfo.gov/content/pkg/FR-2017-11-20/pdf/2017-25065.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing that it has received a petition requesting exemption from the premarket notification requirements for over-the-counter (OTC) denture repair kits. These devices consist of material, such as...  

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