Company ยท US
Satelec
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2011. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ELC | Scaler, Ultrasonic | 6 |
| EBZ | Activator, Ultraviolet, For Polymerization | 4 |
| EFB | Handpiece, Air-Powered, Dental | 4 |
| DZI | Drill, Bone, Powered | 3 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 |
| EIA | Unit, Operative Dental | 1 |
| GEX | Powered Laser Surgical Instrument | 1 |
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | 1 |
| LBK | Neurosurgical Ultrasonic Instruments | 1 |
| LWM | Device, Electrical Dental Anesthesia | 1 |
| MVL | Cord, Retraction | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 8, 2011 | K110379 | AIR-N-GO Satelec | EFB |
| Apr 28, 2010 | K100410 | PIEZOELECTRIC SYSTEM Satelec | JDX |
| Dec 11, 2009 | K091331 | PIEZOTOME 2 Satelec | DZI |
| Jul 22, 2009 | K091252 | IMPLANT CENTER 2 Satelec | DZI |
| Dec 17, 2008 | K082116 | HEMOSTASYL PASTE Satelec | MVL |
| Sep 19, 2007 | K072181 | MINI LED AUTOFOCUS Satelec | EBZ |
| Sep 10, 2007 | K071965 | I-SURGE Satelec | EFB |
| May 3, 2006 | K060275 | PIEZOTOME Satelec | ELC |
| May 1, 2006 | K060274 | PIEZOTOME Satelec | DZI |
| Jan 25, 2006 | K053328 | BIOSPLINT SPLINTING RIBBON Satelec | EBI |
| Apr 20, 2005 | K050895 | SURPASSON P5 NEWTRON Satelec, FR | ELC |
| Dec 17, 2004 | K042787 | IS 40 MICROMOTOR Satelec | EFB |
| Aug 19, 2004 | K040529 | COCOON HYGIENIST Satelec | EIA |
| Apr 28, 2004 | K040808 | MINI L.E.D. OEM MODULE Satelec | EBZ |
| Mar 1, 2004 | K033764 | SP NEWTRON MODULE Satelec, FR | ELC |
| Oct 21, 2003 | K032465 | MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI Satelec | EBZ |
| Jun 7, 2001 | K011001 | TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM Satelec | LWM |
| Apr 4, 2000 | K000049 | SUNI MAX Satelec | EFB |
| Oct 8, 1997 | K972612 | DISSECTRON PORTABLE UNIT Satelec | LBK |
| Jul 9, 1997 | K972026 | SP4044 & SP4055 LUX MODULES Satelec | ELC |
| Jul 31, 1996 | K961735 | ACTA Satelec | EBZ |
| May 23, 1996 | K961158 | SUPRASSON P5 BOOSTER Satelec | ELC |
| Sep 29, 1995 | K942139 | SUPRASSON P MAX Satelec, FR | ELC |
| Nov 7, 1990 | K904067 | LASERSAT CO2 Satelec, FR | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||