---
kind: "section"
citation: "21 C.F.R. § 872.6670"
title: "21"
number: "872.6670"
heading: "Silicate protector."
url: "https://uscodex.org/cfr/21/872.6670"
---

# §872.6670. Silicate protector.

- (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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 872.9](/cfr/21/872.9.md). 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](/cfr/21/part820.md) of this chapter, except for requirements concerning records and complaint files under [§ 820.35](/cfr/21/820.35.md) of this chapter.

## Notes

### Amendments

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989; 66 FR 38800, July 25, 2001; 90 FR 55984, Dec. 4, 2025]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 30097, Aug. 12, 1987, unless otherwise noted.

### Amendments

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989; 66 FR 38800, July 25, 2001; 90 FR 55984, Dec. 4, 2025]