← Product Code [KIF](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF) · K010940

# SEALAPEX 4 (K010940)

_Sybron Dental Specialties, Inc. · KIF · Jun 20, 2001 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K010940

## Device Facts

- **Applicant:** Sybron Dental Specialties, Inc.
- **Product Code:** [KIF](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF.md)
- **Decision Date:** Jun 20, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3820
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K010940](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K010940)

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