Source: https://www.law.cornell.edu/cfr/text/21/872.3140
Timestamp: 2015-10-04 08:08:26
Document Index: 678709422

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

21 CFR 872.3140 - Resin applicator. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter H › Part 872 › Subpart D › Section 872.3140 21 CFR 872.3140 - Resin applicator.
§ 872.3140
A resin applicator is a brushlike device intended for use in spreading dental resin on a tooth during application of tooth shade material.
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.
§ 872.3140 Resin applicator.
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.