Company ยท DE
Sirona Dental Systems GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2016. Name variants (Inc, Corp, punctuation) are merged.
42510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | 7 |
| EIH | Powder, Porcelain | 6 |
| EIA | Unit, Operative Dental | 4 |
| EHD | Unit, X-Ray, Extraoral With Timer | 3 |
| ELC | Scaler, Ultrasonic | 3 |
| ELW | Material, Impression | 3 |
| GEX | Powered Laser Surgical Instrument | 3 |
| OAS | X-Ray, Tomography, Computed, Dental | 3 |
| EFB | Handpiece, Air-Powered, Dental | 2 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 2 |
| NHA | Abutment, Implant, Dental, Endosseous | 2 |
| EBW | Controller, Foot, Handpiece And Cord | 1 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 |
| KOJ | Airbrush | 1 |
| LLZ | System, Image Processing, Radiological | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 2, 2016 | K160099 | CEREC SpeedGlaze Sirona Dental Systems GmbH, DE | EIH |
| Jul 24, 2015 | K151045 | TENEO Dental Treatment Unit and Accessories Sirona Dental Systems GmbH, DE | EIA |
| Jul 17, 2015 | K150909 | INTEGO Family and Accesories Sirona Dental Systems GmbH, DE | EIA |
| Jul 2, 2015 | K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray Sirona Dental Systems GmbH, DE | EGS |
| May 8, 2015 | K150217 | ORTHOPHOS SL Sirona Dental Systems GmbH, DE | OAS |
| May 30, 2014 | K131319 | T1/T2/T3 TURBINE FAMILY Sirona Dental Systems GmbH, DE | EFB |
| Dec 11, 2013 | K132773 | SIDEXIS 4 Sirona Dental Systems GmbH, DE | LLZ |
| Apr 8, 2013 | K123664 | INCORIS ZI Sirona Dental Systems GmbH, DE | EIH |
| Mar 20, 2013 | K123952 | CEREC BLOCS C IN Sirona Dental Systems GmbH, DE | EIH |
| Mar 15, 2013 | K123070 | GALILEOS FAMILY Sirona Dental Systems GmbH, DE | OAS |
| Feb 1, 2013 | K123545 | INCORIS TZI Sirona Dental Systems GmbH, DE | EIH |
| Feb 17, 2012 | K111421 | SIRONA DENTAL CAD/CAM SYSTEM Sirona Dental Systems GmbH, DE | NHA |
| Mar 22, 2011 | K103711 | ORTHOPHOS XG 3D / CEPH Sirona Dental Systems GmbH, DE | OAS |
| Feb 15, 2011 | K103753 | SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER Sirona Dental Systems GmbH, DE | GEX |
| Oct 22, 2010 | K100152 | SIRONA CAD/CAM SYSTEM Sirona Dental Systems GmbH, DE | NHA |
| Dec 3, 2009 | K092660 | SIROLASER ADVANCE Sirona Dental Systems GmbH, DE | GEX |
| Dec 23, 2008 | K083344 | HELIODENT PLUS Sirona Dental Systems GmbH, DE | EHD |
| Aug 26, 2008 | K081903 | XIOS PLUS WALL-MODULE Sirona Dental Systems GmbH, DE | MUH |
| Apr 11, 2008 | K080882 | CEREC OPTI SPRAY Sirona Dental Systems GmbH, DE | ELW |
| Feb 14, 2008 | K072107 | PERIOSCAN, MODEL: D 3496 Sirona Dental Systems GmbH, DE | ELC |
| Sep 12, 2006 | K062509 | INCORIS ZI Sirona Dental Systems GmbH, DE | EIH |
| Sep 8, 2006 | K062506 | INCORIS AL Sirona Dental Systems GmbH, DE | EIH |
| Apr 14, 2006 | K060892 | GALILEOS Sirona Dental Systems GmbH, DE | MUH |
| Mar 31, 2006 | K052515 | SIROENDO Sirona Dental Systems GmbH | EKX |
| Jan 18, 2006 | K053161 | SIROLASER Sirona Dental Systems GmbH, DE | GEX |
| Sep 6, 2005 | K051661 | IMPLANT HANDPIECES Sirona Dental Systems GmbH | EKX |
| Mar 21, 2005 | K050354 | PERIOSCAN ULTRASONIC SCALER Sirona Dental Systems GmbH | ELC |
| Feb 23, 2004 | K033812 | SIROAIR L AIR SCALER Sirona Dental Systems GmbH | EFB |
| Jan 15, 2004 | K033675 | PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER Sirona Dental Systems GmbH | KOJ |
| Dec 12, 2003 | K033640 | SIROSON L AND SIROSONIC L ULTRASONIC SCALERS Sirona Dental Systems GmbH | ELC |
| Nov 14, 2003 | K032543 | SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES Sirona Dental Systems GmbH | EIA |
| Oct 10, 2003 | K033073 | ORTHOPHOS XG DS/CEPH Sirona Dental Systems GmbH | EHD |
| Aug 19, 2003 | K031584 | SIROTORQUE L Sirona Dental Systems GmbH | EBW |
| Dec 6, 2001 | K013659 | MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM Sirona Dental Systems GmbH | MUH |
| Dec 6, 2001 | K013650 | ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD Sirona Dental Systems GmbH | MUH |
| Nov 1, 2001 | K012517 | CEREC3 VITABLOCKS Sirona Dental Systems GmbH | ELW |
| May 2, 2000 | K000672 | HELIODENT VARIO Sirona Dental Systems GmbH | EHD |
| Feb 8, 2000 | K994172 | CEREC 3 Sirona Dental Systems GmbH | ELW |
| Aug 23, 1999 | K992644 | SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM Sirona Dental Systems GmbH | MUH |
| Apr 30, 1999 | K990528 | ORTHOPHOS 3/3 CEPH/3 DS Sirona Dental Systems GmbH | MUH |
| Dec 11, 1998 | K983242 | SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES Sirona Dental Systems GmbH | EIA |
| Oct 22, 1998 | K983057 | ORTHOPHOS 5/PLUS/CD Sirona Dental Systems GmbH | MUH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||