← Product Code [EKM](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM) · K850863

# ULTRAFIL-LT (GUTTA PERCHA) (K850863)

_The Hygenic Corp. · EKM · Apr 16, 1985 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K850863

## Device Facts

- **Applicant:** The Hygenic Corp.
- **Product Code:** [EKM](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM.md)
- **Decision Date:** Apr 16, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3850
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K850863](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K850863)

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