← Product Code [EBC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC) · K011491

# HELIOSEAL CLEAR CHROMA (K011491)

_Ivoclar North America, Inc. · EBC · Aug 16, 2001 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC/K011491

## Device Facts

- **Applicant:** Ivoclar North America, Inc.
- **Product Code:** [EBC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC.md)
- **Decision Date:** Aug 16, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3765
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC/K011491](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC/K011491)

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