← Product Code [EBC](/productcode/EBC) · K802562

# PRISMA SEAL (K802562)

_Dentsply Intl. · EBC · Nov 12, 1980 · Dental · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K802562

## Device Facts

- **Applicant:** Dentsply Intl.
- **Product Code:** [EBC](/productcode/EBC.md)
- **Decision Date:** Nov 12, 1980
- **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-staging.innolitics.com/device/K802562](https://fda-staging.innolitics.com/device/K802562)

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