← Product Code [LBH](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LBH) · K010255

# CAVITY VARNISH (K010255)

_Rite-Dent Manufacturing Corp. · LBH · Apr 20, 2001 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LBH/K010255

## Device Facts

- **Applicant:** Rite-Dent Manufacturing Corp.
- **Product Code:** [LBH](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LBH.md)
- **Decision Date:** Apr 20, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3260
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory 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.

## 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.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LBH/K010255](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LBH/K010255)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com