Source: https://www.law.cornell.edu/cfr/text/21/872.3220
Timestamp: 2017-01-23 13:14:44
Document Index: 234503678

Matched Legal Cases: ['art 872', '§ 872', '§ 872', 'art 807', '§ 872', 'art 820', '§ 820', '§ 820', 'art 872']

21 CFR 872.3220 - Facebow. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter H › Part 872 › Subpart D › Section 872.3220 21 CFR 872.3220 - Facebow.
§ 872.3220 Facebow.
(a)Identification. A facebow is a device intended for use in denture fabrication to determine the spatial relationship between the upper and lower jaws. This determination is intended for use in placing denture casts accurately into an articulator (§ 872.3150) and thereby aiding correct placement of artificial teeth into a denture base.
(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. If the device is not labeled or otherwise represented as sterile, the device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exceptions of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
Title 21 published on 2015-12-03.No entries appear in the Federal Register after this date, for 21 CFR Part 872.