(a) Identification. Intraoral dental wax is a device made of wax intended to construct patterns from which custom made metal dental prostheses, such as crowns and bridges, are cast. In orthodontic dentistry, the device is intended to make a pattern of a patient's bite to make study models of the teeth.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in Sec. 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of Sec. 820.180, with respect to general requirements concerning records, and Sec. 820.198, with respect to complaint files. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38800, July 25, 2001]