← Product Code [EKZ](/submissions/DE/subpart-e%E2%80%94surgical-devices/EKZ) · K852522

# SATALEC SERVOTOME (K852522)

_Spelna, Inc. · EKZ · Dec 27, 1985 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKZ/K852522

## Device Facts

- **Applicant:** Spelna, Inc.
- **Product Code:** [EKZ](/submissions/DE/subpart-e%E2%80%94surgical-devices/EKZ.md)
- **Decision Date:** Dec 27, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.4920
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A dental electrosurgical unit and accessories is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. This device is intended to cut or remove soft tissue or to control bleeding during surgical procedures in the oral cavity. An electrical current passes through the tip of the electrode into the tissue and, depending upon the operating mode selected, cuts through soft tissue or coagulates the tissue.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKZ/K852522](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKZ/K852522)

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