(a) Identification. An endodontic silver point is a device made of silver intended for use during endodontic therapy to fill permanently the root canal of a tooth.

(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 §872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38798, July 25, 2001]