Satalec Servotome
by Spelna, Inc.
510(k) K852522
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK852522 | Date27 Dec 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EKZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.4920
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Satalek Servotome is a unit, electrosurgical, and accessory device for dental use. It is classified as a Class II medical device under regulation number 872.4920.
The device received FDA 510(k) clearance (K852522) on December 27, 1985, and was found substantially equivalent. It is manufactured by Spelna, Inc. and assigned product code EKZ.
Other devices from Spelna, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the Satalek Servotome used for?
The Satalek Servotome is an electrosurgical unit and accessory designed for dental use, intended to perform cutting and coagulation of soft tissue during dental procedures using high-frequency electrical current.
How is the Satalek Servotome supplied and is it reusable?
The Satalek Servotome is supplied as a reusable electrosurgical unit and its associated accessories; it is not a single-use device and is intended for repeated use after appropriate cleaning and sterilization between patients.
What regulatory pathway was used for the Satalek Servotome and when was it cleared?
The Satalek Servotome received FDA 510(k) clearance through the traditional pathway under K852522 on December 27, 1985, and was determined to be substantially equivalent to a legally marketed predicate device.