← Product Code [EBC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC) · K890494

# FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS (K890494)

_Macrochem Corp. · EBC · Mar 29, 1989 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC/K890494

## Device Facts

- **Applicant:** Macrochem Corp.
- **Product Code:** [EBC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC.md)
- **Decision Date:** Mar 29, 1989
- **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/K890494](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC/K890494)

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