21 CFR § 872.6670 - Silicate protector.

---
identifier: "/us/cfr/t21/s872.6670"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 872.6670 - Silicate protector."
title_number: 21
title_name: "Food and Drugs"
section_number: "872.6670"
section_name: "Silicate protector."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "872"
part_name: "DENTAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 30097, Aug. 12, 1987, unless otherwise noted."
cfr_part: "872"
---


# 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 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.

[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]