Not currently registered with FDA under this name
Spelna, Inc.
Fredericksburg, VA, United States. Named as applicant on 8 dental 510(k) clearances between 1983 and 1986. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 81983–1986
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1980–2026
510(k) clearances
Clearances on which FDA names Spelna, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 30 Jan 1986 | K852525 | SATALEC PIEZOTEC | ELC Ultrasonic Scaler |
| 27 Dec 1985 | K852522 | SATALEC SERVOTOME | EKZ Dental Electrosurgical Unit and Accessories |
| 31 Jul 1985 | K852524 | SATALEC SERVOTORQUE S2 SX2 | EIA Operative Dental Unit |
| 31 Jul 1985 | K852521 | SATLEC PROPHY UNIT PU 3055 | KOJ Airbrush |
| 16 Mar 1984 | K832674 | SATELEC PROPHY UNIT PU 2000S | ELC Ultrasonic Scaler |
| 16 Mar 1984 | K832664 | SATELEC SUPRASSON PIEZOMATIC P2 | ELC Ultrasonic Scaler |
| 19 Oct 1983 | K832673 | SATELEC PROPHY UNIT PU-2000 | EIA Operative Dental Unit |
| 19 Oct 1983 | K832665 | SATELEC SUPRASSON SP 3055 | ELC Ultrasonic Scaler |
Some of these clearances are listed with FDA today by another company: Satelec - Acteon Group (4).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.