Satelec
Medical device manufacturer in Mt. Laurel, NJ.
24510(k) clearances
0PMA approvals
0recalls
Device types
- ELC Scaler, Ultrasonic 6
- EBZ Activator, Ultraviolet, For Polymerization 4
- EFB Handpiece, Air-Powered, Dental 4
- DZI Drill, Bone, Powered 3
- GEX Powered Laser Surgical Instrument 1
- LBK Neurosurgical Ultrasonic Instruments 1
- LWM Device, Electrical Dental Anesthesia 1
- EIA Unit, Operative Dental 1
- EBI Resin, Denture, Relining, Repairing, Rebasing 1
- MVL Cord, Retraction 1
- JDX Instrument, Surgical, Sonic And… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K110379 | Air-N-GoEFB · Traditional | 12/08/2011SE |
| K100410 | Piezoelectric SystemJDX · Traditional | 04/28/2010SE |
| K091331 | Piezotome 2DZI · Traditional | 12/11/2009SE |
| K091252 | Implant Center 2DZI · Traditional | 07/22/2009SE |
| K082116 | Hemostasyl PasteMVL · Traditional | 12/17/2008SE |
| K072181 | Mini LED AutofocusEBZ · Traditional | 09/19/2007SE |
| K071965 | I-SurgeEFB · Traditional | 09/10/2007SE |
| K060275 | PiezotomeELC · Traditional | 05/03/2006SE |
| K060274 | PiezotomeDZI · Traditional | 05/01/2006SE |
| K053328 | Biosplint Splinting RibbonEBI · Traditional | 01/25/2006SE |
| K050895 | Surpasson P5 NewtronELC · Traditional | 04/20/2005SE |
| K042787 | Is 40 MicromotorEFB · Traditional | 12/17/2004SE |
| K040529 | Cocoon HygienistEIA · Traditional | 08/19/2004SE |
| K040808 | Mini L.E.D. Oem ModuleEBZ · Traditional | 04/28/2004SE |
| K033764 | SP Newtron ModuleELC · Traditional | 03/01/2004SE |
| K032465 | Mini L.E.D., Model: Mini L.E.D., Model Smartlite MiniEBZ · Traditional | 10/21/2003SE |
| K011001 | Team-Up TM Dental Electronic Anesthesia SystemLWM · Traditional | 06/07/2001SE |
| K000049 | Suni MaxEFB · Traditional | 04/04/2000SE |
| K972612 | Dissectron Portable UnitLBK · Traditional | 10/08/1997SE |
| K972026 | SP4044 & SP4055 Lux ModulesELC · Traditional | 07/09/1997SE |
| K961735 | ActaEBZ · Traditional | 07/31/1996SE |
| K961158 | Suprasson P5 BoosterELC · Traditional | 05/23/1996SE |
| K942139 | Suprasson P MaxELC · Traditional | 09/29/1995SE |
| K904067 | Lasersat CO2GEX · Traditional | 11/07/1990SE |