Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3260](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3260) → PME — External Cleaning Solution

# PME · External Cleaning Solution

_Dental · 21 CFR 872.3260 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PME

## Overview

- **Product Code:** PME
- **Device Name:** External Cleaning Solution
- **Regulation:** [21 CFR 872.3260](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3260)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)

## 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.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K191133](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PME/K191133.md) | KATANA Cleaner, KATANA Cleaner (Trial) | Kuraray Noritake Dental, Inc. | Oct 8, 2019 | SESE |
| [K163171](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PME/K163171.md) | CeraClean | Bisco, Inc. | Apr 14, 2017 | SESE |
| [K152322](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PME/K152322.md) | Resolve 2.0 | Denali Corporation | Dec 16, 2015 | SESE |

## Top Applicants

- Bisco, Inc. — 1 clearance
- Denali Corporation — 1 clearance
- Kuraray Noritake Dental, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PME](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/PME)

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