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Data / Medical devices / United States / Dentsply Sirona Inc

Dentsply Sirona Inc: FDA-registered device maker in York, PA, United States, 40 510(k) clearances

Dentsply Sirona Inc is registered with the FDA (registration 3004884150) in York, PA, United States. It lists 34 device types. The FDA files 40 510(k) clearances under its listings, the newest dated August 29, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Dentsply Sirona Inc
FDA registration number
3004884150
Address
221 W Philadelphia St Ste 60w, York, PA, United States, 17401
Owner or operator
DENTSPLY SIRONA INC (2511302)
Roles
Complaint file establishment
First device listed
July 2, 1987
Registered through
2026
Brand names listed
Celtra® Duo and Cerec® Zirconia Blocks & Materials Starter Kit, Midwest E mini, OSSIX Plus, OSSIX VOLUMAX, OSSIX™ Bone, Ossix Agile, Ossix Breeze, Tube Extension

Devices it lists

DeviceProduct codeClassRoleSource
Abutment, Implant, Dental, EndosseousNHA2Complaint file establishmentaccessdata.fda.gov
Accessories, Implant, Dental, EndosseousNDP1Complaint file establishmentaccessdata.fda.gov
Activator, Ultraviolet, For PolymerizationEBZ2Complaint file establishmentaccessdata.fda.gov
Alloy, Metal, BaseEJH2Complaint file establishmentaccessdata.fda.gov
Barrier, Animal Source, IntraoralNPL2Complaint file establishmentaccessdata.fda.gov
Bone Grafting Material, Animal SourceNPM2Complaint file establishmentaccessdata.fda.gov
Controller, Foot, Handpiece And CordEBW1Complaint file establishmentaccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Complaint file establishmentaccessdata.fda.gov
Dental Abutment Design Software For Dental LaboratoryPNP2Complaint file establishmentaccessdata.fda.gov
Handpiece, Air-Powered, DentalEFB1Complaint file establishmentaccessdata.fda.gov
Handpiece, Belt And/Or Gear Driven, DentalEFA1Complaint file establishmentaccessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, DentalEGS1Complaint file establishmentaccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Complaint file establishmentaccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Complaint file establishmentaccessdata.fda.gov
Light Transmission Caries DetectorNTK2Complaint file establishmentaccessdata.fda.gov
Light, Operating, DentalEAZ1Complaint file establishmentaccessdata.fda.gov
Light-Induced Fluorescence Caries Detector NBL2Complaint file establishmentaccessdata.fda.gov
Maintainer, Space Preformed, OrthodonticDYT1Complaint file establishmentaccessdata.fda.gov
Material, ImpressionELW2Complaint file establishmentaccessdata.fda.gov
Material, Impression Tray, ResinEBH1Complaint file establishmentaccessdata.fda.gov
Mouthguard, PrescriptionMQCUComplaint file establishmentaccessdata.fda.gov
Orthodontic SoftwarePNN2Complaint file establishmentaccessdata.fda.gov
Positioner, Tooth, PreformedKMY1Complaint file establishmentaccessdata.fda.gov
Powder, PorcelainEIH2Complaint file establishmentaccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Complaint file establishmentaccessdata.fda.gov
Retainer, Screw Expansion, OrthodonticDYJ1Complaint file establishmentaccessdata.fda.gov
Scaler, UltrasonicELC2Complaint file establishmentaccessdata.fda.gov
Shield, Eye, RadiologicalIWS1Complaint file establishmentaccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Complaint file establishmentaccessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsNOF2Complaint file establishmentaccessdata.fda.gov
Unit, Operative DentalEIA1Complaint file establishmentaccessdata.fda.gov
Unit, Oral IrrigationEFS1Complaint file establishmentaccessdata.fda.gov
Unit, X-Ray, Extraoral With TimerEHD2Complaint file establishmentaccessdata.fda.gov
X-Ray, Tomography, Computed, DentalOAS2Complaint file establishmentaccessdata.fda.gov

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 29, 2025K250771Primescan 2NTKSubstantially EquivalentDentsply Sirona, Inc.accessdata.fda.gov
April 30, 2025K250295Dentsply Sirona Titanium Bases systemNHASubstantially EquivalentDentsply Sironaaccessdata.fda.gov
October 12, 2023K232448FREEPRINT® splintmasterMQCSubstantially EquivalentDetax GmbHaccessdata.fda.gov
July 18, 2022K212509OSSIX BreezeNPLSubstantially EquivalentDatum Dental, Ltd.accessdata.fda.gov
October 27, 2020K200273FREEPRINT tempEBGSubstantially EquivalentDetax GmbH & Co. KGaccessdata.fda.gov
August 16, 2020K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareNHASubstantially EquivalentDentsply Sironaaccessdata.fda.gov
June 22, 2020K201140AxeosOASSubstantially EquivalentDentsply Sironaaccessdata.fda.gov
September 27, 2019K190059CEREC GuidesNDPSubstantially EquivalentDentsply Sironaaccessdata.fda.gov
July 16, 2019K191616Orthophos SOASSubstantially EquivalentDentsply Sironaaccessdata.fda.gov
October 11, 2018K181520Sirona Dental CAD/CAM SystemNHASubstantially EquivalentDentsply Sironaaccessdata.fda.gov
August 1, 2018K180703VITA YZ ST and VITA YZ XTEIHSubstantially EquivalentVita Zahnfabrik H.Rauter GmbH Co.accessdata.fda.gov
March 8, 2018K180044SIROLaser BlueGEXSubstantially EquivalentDentsply Sironaaccessdata.fda.gov
January 11, 2018K171122CEREC Ortho SoftwarePNNSubstantially EquivalentDentsply Sironaaccessdata.fda.gov
July 18, 2017K163714OSSIX BONENPMSubstantially EquivalentDatum Dental, Ltd.accessdata.fda.gov
May 16, 2017K170500SIROLaser Advance+GEXSubstantially EquivalentDentsply Sironaaccessdata.fda.gov
August 4, 2016K160281OSSIX PLUSNPLSubstantially EquivalentDatum Dental, Ltd.accessdata.fda.gov
August 4, 2016K153549OSSIX VOLUMAXNPLSubstantially EquivalentDatum Dental, Ltd.accessdata.fda.gov
July 24, 2015K151045TENEO Dental Treatment Unit and AccessoriesEIASubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
July 17, 2015K150909INTEGO Family and AccesoriesEIASubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
July 2, 2015K150750Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SprayEGSSubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
May 8, 2015K150217ORTHOPHOS SLOASSubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
May 30, 2014K131319T1/T2/T3 TURBINE FAMILYEFBSubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
February 25, 2014K133320SICAT FUNCTIONLLZSubstantially EquivalentSicat GmbH & Co. KGaccessdata.fda.gov
December 11, 2013K132773SIDEXIS 4LLZSubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
March 15, 2013K123070GALILEOS FAMILYOASSubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
February 1, 2013K123545INCORIS TZIEIHSubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
February 17, 2012K111421SIRONA DENTAL CAD/CAM SYSTEMNHASubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
March 22, 2011K103711ORTHOPHOS XG 3D / CEPHOASSubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
February 15, 2011K103753SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASERGEXSubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
October 22, 2010K100152SIRONA CAD/CAM SYSTEMNHASubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
August 11, 2010K102128VITABLOCSEIHSubstantially EquivalentVita Zahnfabrik H.Rauter GmbH & Co.accessdata.fda.gov
December 23, 2008K083344HELIODENT PLUSEHDSubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
April 11, 2008K080882CEREC OPTI SPRAYELWSubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
September 6, 2005K051661IMPLANT HANDPIECESEKXSubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
September 2, 2005K052334CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131ELCSubstantially EquivalentDentsply Intl.accessdata.fda.gov
April 28, 2004K040808MINI L.E.D. OEM MODULEEBZSubstantially EquivalentSatelecaccessdata.fda.gov
December 12, 2003K033640SIROSON L AND SIROSONIC L ULTRASONIC SCALERSELCSubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
October 10, 2003K033073ORTHOPHOS XG DS/CEPHEHDSubstantially EquivalentSirona Dental Systems GmbHaccessdata.fda.gov
September 22, 1997K972436T1 LINE DENTAL HANDPIECESEFBSubstantially EquivalentSiemens AGaccessdata.fda.gov
March 19, 1997K965238T1 CONTROL HIGH SPEED DENTAL HANDPIECEEFASubstantially EquivalentSiemens AGaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
March 20, 200951469Not yet classifiedTerminatedDentsply, MAILLEFER, CYTCO-K TITANIUM POST SYSTEM, dental implant components, Model numbers (SKU): C106KL0050A20 (12 posts) and C117K00000020 (4 posts), Swiss Made, Manufactured for DENTSPLY Maillefer, Johnson City, TN 3The product is manufactured with a left-hand thread instead of a right hand thread. This error could cause tooth breakage if the posts were removed without knowing that the threads were reversed.accessdata.fda.gov

Compare with other makers

Updated August 29, 2025. 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.