Ems Kermit
by (Ems Sa) Electro Medical Systems
510(k) K992504
Ems Kermit is a Class II device made by (Ems Sa) Electro Medical Systems, cleared under FDA 510(k) K992504 on 27 Jan 2000, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992504 | Date27 Jan 2000 | StatusActive |
Official records
- FDA 510(k) database K992504
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ELC
- Device class
- Class II
- Regulation
- 21 CFR Part 872.4850
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code ELC (Scaler, Ultrasonic).
- XP TECHNOLOGY ULTRASONIC SCALER by American Eagle Instruments
- INSIGHT ULTRASONIC INSERTS by Discus Dental, Inc.
- NEWTRON BOOSTER by Satelec - Acteon Group
- ULTRASONIC DENTAL PROPHYLAXIS DEVICE by Cavitron Corp.
- J. MORITA AZ ULTRASONIC SYSTEM by J. MORITA U.S.A., INC
- SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM by HU-FRIEDY MFG CO., LLC
- SUPRASSON P MAX by Satelec
- EVOCLEAN CLEANsert Ultrasonic Insert by TTBIO CORP.
- SONUS III by Litton Dental Products
- SATELEC SUPRASSON PIEZOMATIC P2 by Spelna, Inc.