PME · External Cleaning Solution
Dental · 21 CFR 872.3260 · Class 2
Overview
| Product Code | PME |
|---|---|
| Device Name | External Cleaning Solution |
| Regulation | 21 CFR 872.3260 |
| Device Class | Class 2 |
| Review Panel | Dental |
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.
Special Controls
*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.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K191133 | KATANA Cleaner, KATANA Cleaner (Trial) | Kuraray Noritake Dental, Inc. | Oct 8, 2019 | SESE |
| K163171 | CeraClean | Bisco, Inc. | Apr 14, 2017 | SESE |
| K152322 | Resolve 2.0 | Denali Corporation | Dec 16, 2015 | SESE |
Top Applicants
- Kuraray Noritake Dental, Inc. — 1 clearance
- Denali Corporation — 1 clearance
- Bisco, Inc. — 1 clearance
