Title 21

SECTION 872.6050

872.6050 Saliva absorber.

§ 872.6050 Saliva absorber.

(a) Identification. A saliva absorber is a device made of paper or cotton intended to absorb moisture from the oral cavity during dental procedures.

(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, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38799, July 25, 2001]

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