Dentsply Sirona Inc
Also registered as Dentsply Sirona
Country not established FDA establishment FEI 3004884150
- Devices
- 88
- Registrations
- FDA
- FDA recalls
- 0
What Dentsply Sirona Inc makes
DENTSPLY SIRONA INC manufactures the X-Smart Pro device, which is a Class I medical device.
The company is based in the US and its devices are listed in the FDA 510(k) registry.
AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.
Device · Authorizations
Atlantis suprastructures Ref K193064
Class IIActive 510(k) 510(k) IIMIS CONNECT Conical Connection System Ref K193078
Class IIActive 510(k) 510(k) IICEREC Tessera Abutment System Ref K252248
Class IIActive 510(k) 510(k) IIDentsply Sirona Universal Spray Glazes Ref K202629
Class IIActive 510(k) 510(k) IISureSmile Aligner (ASSY500020) Ref K260722
Class IIActive 510(k) 510(k) IIPrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) Ref K220841
Class IIActive 510(k) 510(k) IICEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System Ref K234018
Class IIActive 510(k) 510(k) IIMidwest Rhino XE and Air Motor M Ref K192409
Class IActive 510(k) 510(k) ICEREC Cercon 4D CAD/CAM Blocks Ref K242462
Class IIActive 510(k) 510(k) IIAtlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants Ref K251205
Class IIActive 510(k) 510(k) IINavina Classic System Ref K170487
Class IIActive 510(k) 510(k) IISirona Dental CAD/CAM System Ref K181520
Class IIActive 510(k) 510(k) IISurgical and Prosthetic Trays Ref K220791
Class IIActive 510(k) 510(k) IIMotor and Apex Module (MaAM) Ref K251811
Class IActive 510(k) 510(k) IPour Acrylic Ref K161330
Class IIActive 510(k) 510(k) IILucitone Digital Print Denture™ System Ref K243336
Class IIActive 510(k) 510(k) IIMIS Dental Implant System Ref K200102
Class IIActive 510(k) 510(k) IIPrimeTaper EV Dental Implant Ref K210610
Class IIActive 510(k) 510(k) IIStainless Steel Surgical Kits Ref K251614
Class IIActive 510(k) 510(k) IIATLANTIS Abutment for HIOSSEN ET implant Ref K160626
Class IIActive 510(k) 510(k) IIDS Implants abutments provided with the EV connection Ref K213449
Class IIActive 510(k) 510(k) IIPrimescan 2 Ref K250771
Class IIActive 510(k) 510(k) IICalibra Abutment Resin Cement Ref K240888
Class IIActive 510(k) 510(k) IIPropex IQ Apex Locator Ref K191806
UnclassifiedActive 510(k) 510(k) —Multibase Abutments EV and ATLANTIS Suprastructures Ref K163350
Class IIActive 510(k) 510(k) IIAtlantis® Abutments in Titanium Ref K250081
Class IIActive 510(k) 510(k) IIByte Aligner System Ref K230199 Open recall
Class IIActive 510(k) 510(k) IIMIS LYNX Conical Connection Implant System Ref K251297
Class IIActive 510(k) 510(k) IIWashtrays Ref K231144
Class IIActive 510(k) 510(k) IIMIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology Ref K160825
Class IActive 510(k) 510(k) IOrthophos S Ref K191616
Class IIActive 510(k) 510(k) IISurgical Trays Ref K212281
Class IIActive 510(k) 510(k) IIPrimevision 3D Ref K253959
Class IIActive 510(k) 510(k) IISIROLaser Advance+ Ref K170500
Class IIActive 510(k) 510(k) IIMIS LYNX Conical Connection Implant System Ref K241692
Class IIActive 510(k) 510(k) IISimPro™ Now, GentleCath™ Hydrophilic Ref K223756
Class IIActive 510(k) 510(k) IIATLANTIS suprastructures Ref K163398
Class IIActive 510(k) 510(k) IICercon Ref K162888
Class IIActive 510(k) 510(k) II
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Company details
- FDA FEI number
- 3004884150
- Address
- 221 W Philadelphia St Ste 60w, York, PA, 17401
This is an FDA establishment record. No EUDAMED registration is known for this company and no recalls are recorded.