← Product Code [LBH](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LBH) · K833701

# ACA THYROXINE ANALYTICAL TEST PACK (K833701)

_E.I. Dupont DE Nemours & Co., Inc. · LBH · Jan 13, 1984 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94prosthetic-devices/LBH/K833701

## Device Facts

- **Applicant:** E.I. Dupont DE Nemours & Co., Inc.
- **Product Code:** [LBH](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/LBH.md)
- **Decision Date:** Jan 13, 1984
- **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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94prosthetic-devices/LBH/K833701](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94prosthetic-devices/LBH/K833701)

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