← Product Code [EBC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC) · K831380

# DELTON LIGHT CURING PIT & FISSURE (K831380)

_Johnson & Johnson Professionals, Inc. · EBC · Jun 30, 1983 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC/K831380

## Device Facts

- **Applicant:** Johnson & Johnson Professionals, Inc.
- **Product Code:** [EBC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC.md)
- **Decision Date:** Jun 30, 1983
- **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/K831380](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC/K831380)

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