(a) Identification. A silicate protector is a device made of silicone intended to be applied with an absorbent tipped applicator to the surface of a new restoration to exclude temporarily fluids from its surface.

(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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.