← Product Code [EBE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBE) · K830491

# JOHNSON & JOHNSON OPAQUE COLOR MODIFI (K830491)

_Johnson & Johnson Professionals, Inc. · EBE · Mar 17, 1983 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBE/K830491

## Device Facts

- **Applicant:** Johnson & Johnson Professionals, Inc.
- **Product Code:** [EBE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBE.md)
- **Decision Date:** Mar 17, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3300
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A hydrophilic resin coating for dentures is a device that consists of a water-retaining polymer that is intended to be applied to the base of a denture before the denture is inserted into the patient's mouth to improve denture retention and comfort.

## Special Controls

*Classification.* Class II (special controls). The device 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/DE/subpart-d%E2%80%94prosthetic-devices/EBE/K830491](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBE/K830491)

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