21 C.F.R. § 872.6030 Oral cavity abrasive polishing agent.
Title 21 - Food and Drugs
(a) Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup). (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 59 FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, 2001]
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart G—Miscellaneous Devices
§ 872.6030 Oral cavity abrasive polishing agent.
