21 CFR 872.3260 — Varnish, Cavity
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3260
Identification
Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.
Classification Rationale
Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LBH | Varnish, Cavity | 2 | 135 | 3rd Party |
| PHR | Diammine Silver Fluoride Dental Hypersensitivity Varnish | 2 | 8 | 3rd Party |
| PME | External Cleaning Solution | 2 | 3 |
Special Controls
LBH — Varnish, Cavity
*Classification.* Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
eCFR
PHR — Diammine Silver Fluoride Dental Hypersensitivity Varnish
*Classification.* Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
eCFR
PME — External Cleaning Solution
*Classification.* Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
eCFR
