Data / Medical devices / Germany / Sirona Dental Systems GMBH
Sirona Dental Systems GMBH: FDA-registered device maker in BENSHEIM Hesse, Germany, 49 510(k) clearances
Sirona Dental Systems GMBH is registered with the FDA (registration 9614977) in BENSHEIM Hesse, Germany. It lists 36 device types. The FDA files 49 510(k) clearances under its listings, the newest dated February 5, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9614977
- FEI number
- 3003719498
- Address
- Fabrikstrasse 31, BENSHEIM Hesse, Germany, D-64625
- Owner or operator
- DENTSPLY SIRONA INC (2511302)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 2, 1987
- Registered through
- 2026
- Brand names listed
- Celtra® Duo and Cerec® Zirconia Blocks & Materials Starter Kit, Contra Angle Heads, Midwest Handpiece,, Midwest E mini, Midwest RDH, Midwest Rhino XP, Midwest Shorty Single Speed Air Motor, Midwest Shorty Two Speed Air Motor and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 5, 2026 | K253959 | Primevision 3D | OAS | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| August 29, 2025 | K250771 | Primescan 2 | NTK | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| August 25, 2025 | K251811 | Motor and Apex Module (MaAM) | EBW | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| April 30, 2025 | K250295 | Dentsply Sirona Titanium Bases system | NHA | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| July 24, 2024 | K233865 | X-Smart Pro; X-Smart Pro+ | EKX | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| October 12, 2023 | K232448 | FREEPRINT® splintmaster | MQC | Substantially Equivalent | Detax GmbH | accessdata.fda.gov |
| October 27, 2020 | K200273 | FREEPRINT temp | EBG | Substantially Equivalent | Detax GmbH & Co. KG | accessdata.fda.gov |
| August 16, 2020 | K193408 | Sirona Dental CAD/CAM System with CEREC Chairside Software | NHA | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| June 22, 2020 | K201140 | Axeos | OAS | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| January 13, 2020 | K192409 | Midwest Rhino XE and Air Motor M | EFB | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| September 27, 2019 | K190059 | CEREC Guides | NDP | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| July 16, 2019 | K191616 | Orthophos S | OAS | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| October 11, 2018 | K181520 | Sirona Dental CAD/CAM System | NHA | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| August 1, 2018 | K180703 | VITA YZ ST and VITA YZ XT | EIH | Substantially Equivalent | Vita Zahnfabrik H.Rauter GmbH Co. | accessdata.fda.gov |
| March 8, 2018 | K180044 | SIROLaser Blue | GEX | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| January 11, 2018 | K171122 | CEREC Ortho Software | PNN | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| May 16, 2017 | K170500 | SIROLaser Advance+ | GEX | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| July 24, 2015 | K151045 | TENEO Dental Treatment Unit and Accessories | EIA | Substantially Equivalent | Sirona Dental Systems GmbH | accessdata.fda.gov |
| July 17, 2015 | K150909 | INTEGO Family and Accesories | EIA | Substantially Equivalent | Sirona Dental Systems GmbH | accessdata.fda.gov |
| July 2, 2015 | K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | EGS | Substantially Equivalent | Sirona Dental Systems GmbH | accessdata.fda.gov |
| May 8, 2015 | K150217 | ORTHOPHOS SL | OAS | Substantially Equivalent | Sirona Dental Systems GmbH | accessdata.fda.gov |
| May 30, 2014 | K131319 | T1/T2/T3 TURBINE FAMILY | EFB | Substantially Equivalent | Sirona Dental Systems GmbH | accessdata.fda.gov |
| February 25, 2014 | K133320 | SICAT FUNCTION | LLZ | Substantially Equivalent | Sicat GmbH & Co. KG | accessdata.fda.gov |
| December 11, 2013 | K132773 | SIDEXIS 4 | LLZ | Substantially Equivalent | Sirona Dental Systems GmbH | accessdata.fda.gov |
| March 15, 2013 | K123070 | GALILEOS FAMILY | OAS | Substantially Equivalent | Sirona Dental Systems GmbH | accessdata.fda.gov |
| February 1, 2013 | K123545 | INCORIS TZI | EIH | Substantially Equivalent | Sirona Dental Systems GmbH | accessdata.fda.gov |
| February 17, 2012 | K111421 | SIRONA DENTAL CAD/CAM SYSTEM | NHA | Substantially Equivalent | Sirona Dental Systems GmbH | accessdata.fda.gov |
| March 22, 2011 | K103711 | ORTHOPHOS XG 3D / CEPH | OAS | Substantially Equivalent | Sirona Dental Systems GmbH | accessdata.fda.gov |
| February 15, 2011 | K103753 | SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER | GEX | Substantially Equivalent | Sirona Dental Systems GmbH | accessdata.fda.gov |
| October 22, 2010 | K100152 | SIRONA CAD/CAM SYSTEM | NHA | Substantially Equivalent | Sirona Dental Systems GmbH | accessdata.fda.gov |
| August 11, 2010 | K102128 | VITABLOCS | EIH | Substantially Equivalent | Vita Zahnfabrik H.Rauter GmbH & Co. | accessdata.fda.gov |
| December 23, 2008 | K083344 | HELIODENT PLUS | EHD | Substantially Equivalent | Sirona Dental Systems GmbH | accessdata.fda.gov |
| April 11, 2008 | K080882 | CEREC OPTI SPRAY | ELW | Substantially Equivalent | Sirona Dental Systems GmbH | accessdata.fda.gov |
| February 4, 2008 | K073319 | STATMATIC 31 HANDPIECE MAINTENANCE UNIT | EFB | Substantially Equivalent | Scican , Ltd. | accessdata.fda.gov |
| September 13, 2007 | K071891 | STATIS DENTAL HANDPIECES | EFB | Substantially Equivalent | Scican , Ltd. | accessdata.fda.gov |
| October 19, 2006 | K062418 | K-SPRAY, MODEL 085-2715 | EFB | Substantially Equivalent | Scican | accessdata.fda.gov |
| August 25, 2006 | K061701 | HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) | EFA | Substantially Equivalent | J. Morita USA, Inc. | accessdata.fda.gov |
| September 6, 2005 | K051661 | IMPLANT HANDPIECES | EKX | Substantially Equivalent | Sirona Dental Systems GmbH | accessdata.fda.gov |
| September 2, 2005 | K052334 | CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 | ELC | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| April 28, 2004 | K040808 | MINI L.E.D. OEM MODULE | EBZ | Substantially Equivalent | Satelec | accessdata.fda.gov |
| December 12, 2003 | K033640 | SIROSON L AND SIROSONIC L ULTRASONIC SCALERS | ELC | Substantially Equivalent | Sirona Dental Systems GmbH | accessdata.fda.gov |
| October 10, 2003 | K033073 | ORTHOPHOS XG DS/CEPH | EHD | Substantially Equivalent | Sirona Dental Systems GmbH | accessdata.fda.gov |
| June 28, 2001 | K011061 | SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 | EGS | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| December 10, 1998 | K983183 | GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P | EFB | Substantially Equivalent | Bien Air USA, Inc. | accessdata.fda.gov |
| September 22, 1997 | K972436 | T1 LINE DENTAL HANDPIECES | EFB | Substantially Equivalent | Siemens AG | accessdata.fda.gov |
| March 19, 1997 | K965238 | T1 CONTROL HIGH SPEED DENTAL HANDPIECE | EFA | Substantially Equivalent | Siemens AG | accessdata.fda.gov |
| April 10, 1980 | K800735 | U-STYLE ADAPTER | EGS | Substantially Equivalent | American Midwest | accessdata.fda.gov |
| December 6, 1979 | K792445 | MW STRAIGHT ATTACHMENT | EGS | Substantially Equivalent | Midwest | accessdata.fda.gov |
| November 27, 1979 | K792302 | LS-100 | EFB | Substantially Equivalent | Midwest | accessdata.fda.gov |
Compare with other makers
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- All makers of Light, Operating, Dental
Updated February 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.