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2021-7-5 · Following is a breakdown of 510(k) exempt and Good Manufacturing Practice (GMP)/Quality System exemptions listed by device class. All devices in this list are 510(k) exempt unless further qualified by a footnote. Only devices annotated by (*) are also exempt from GMP except for general recordkeeping requirements and compliant files. Class I Devices
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Get Price2021-6-21 · Submit reprocessing validation test reports in future dental operative unit 510(k)s and describe how reprocessing was considered in the design of the device (e.g. water source, materials ...
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Get Price2013-12-20 · Bone quality and quantity, implant geometry, and surgical technique adopted may significantly influence implant initial stability and overall success rate of dental implants. Funding Statement The authors thank the College of Dentistry Research Centre and Deanship of Scientific Research at King Saud University, Saudi Arabia for funding this ...
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