Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3300](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3300) → EBE — Coating, Denture Hydrophilic, Resin

# EBE · Coating, Denture Hydrophilic, Resin

_Dental · 21 CFR 872.3300 · Class 2_

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

## Overview

- **Product Code:** EBE
- **Device Name:** Coating, Denture Hydrophilic, Resin
- **Regulation:** [21 CFR 872.3300](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3300)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)

## 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.

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K832500](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBE/K832500.md) | CS-11 | Chema-Scutum, Inc. | Oct 27, 1983 | SESE |
| [K830491](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBE/K830491.md) | JOHNSON & JOHNSON OPAQUE COLOR MODIFI | Johnson & Johnson Professionals, Inc. | Mar 17, 1983 | SESE |
| [K790339](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBE/K790339.md) | CONCEPT II | Richardson Merrel, Inc. | Jul 17, 1979 | SESE |

## Top Applicants

- Chema-Scutum, Inc. — 1 clearance
- Johnson & Johnson Professionals, Inc. — 1 clearance
- Richardson Merrel, Inc. — 1 clearance

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

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