(a)Identification. A retentive and splinting pin is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be placed permanently in a tooth to provide retention and stabilization for a restoration, such as a crown, or to join two or more teeth together.
(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 60 FR 38900, July 28, 1995; 66 FR 38798, July 25, 2001]
Title 21 published on 2014-04-01
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