← Product Code [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE) · K003011

# SELF ETCH BONDING PRIMER (K003011)

_Jeneric/Pentron, Inc. · KLE · Nov 28, 2000 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K003011

## Device Facts

- **Applicant:** Jeneric/Pentron, Inc.
- **Product Code:** [KLE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE.md)
- **Decision Date:** Nov 28, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3200
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K003011](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K003011)

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