Medical devices; exemption from premarket notification; Class II devices; optical impression systems for computer assisted design and manufacturing. Final rule.
The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).
D017076:Computer-Aided Design / Q000145:classification* / Q000295:instrumentation; D003748:Dental Equipment / Q000145:classification*; D004869:Equipment Safety; D006801:Humans; D011476:Prosthodontics / Q000145:classification* / Q000295:instrumentation; D014481:United States; D014486:United States Food and Drug Administration