Chrysalis Intelligence · Sponsors · Dentsply Sirona

Dentsply Sirona

York, PA, US · 52 510(k) clearances

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
52
2020-01-13 → 2026-04-23
Last 12 months
10
Product codes
19
Most recent
2026-04-23
Name variants in FDA filings: Dentsply Sirona / Dentsply Sirona, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NHA Abutment, Implant, Dental, Endosseous Class II Dental 15 2025-12-09
DZE Implant, Endosseous, Root-Form Class II Dental 8 2025-08-21
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Class II General Hospital 5 2026-02-06
EIH Powder, Porcelain Class II Dental 3 2024-10-24
QIH Automated Radiological Image Processing Software Class II Radiology 2 2026-04-23
NXC Aligner, Sequential Class II Dental 2 2026-04-15
OAS X-Ray, Tomography, Computed, Dental Class II Radiology 2 2026-02-05
EBI — — — 2 2024-12-17
EMA Cement, Dental Class II Dental 2 2024-04-02
EZD Catheter, Straight Class II Gastroenterology, Urology 2 2023-05-04
PNN Orthodontic Software Class II Dental 1 2026-03-04
MYN Analyzer, Medical Image Class II Radiology 1 2026-01-07
NTK Light Transmission Caries Detector Class II Dental 1 2025-08-29
EBW Controller, Foot, Handpiece And Cord Class I Dental 1 2025-08-25
KIF — — — 1 2025-02-13
EKX Handpiece, Direct Drive, Ac-Powered Class I Dental 1 2024-07-24
NDP Accessories, Implant, Dental, Endosseous Class I Dental 1 2020-09-02
PNP Dental Abutment Design Software For Dental Laboratory Class II Dental 1 2020-08-19
EFB — — — 1 2020-01-13
Filings

All 510(k) clearances (52)

Date K-number Device Code Class Specialty
2026-04-23 K260785 DS Core CBCT Anatomy QIH Class II Radiology
2026-04-15 K260722 SureSmile Aligner (ASSY500020) NXC Class II Dental
2026-03-04 K253565 SureSmile Software PNN Class II Dental
2026-02-06 K251614 Stainless Steel Surgical Kits KCT Class II General Hospital
2026-02-05 K253959 Primevision 3D OAS Class II Radiology
2026-01-07 K253009 DS Core Detect MYN Class II Radiology
2025-12-09 K252343 Atlantis® Abutments in Titanium NHA Class II Dental
2025-11-26 K252248 CEREC Tessera Abutment System NHA Class II Dental
2025-11-21 K251205 Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants NHA Class II Dental
2025-08-29 K250771 Primescan 2 NTK Class II Dental
2025-08-25 K251811 Motor and Apex Module (MaAM) EBW Class I Dental
2025-08-21 K251647 MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System DZE Class II Dental
2025-08-12 K250755 DS Core Diagnosis QIH Class II Radiology
2025-07-24 K251297 MIS LYNX Conical Connection Implant System DZE Class II Dental
2025-07-22 K251300 Plastic Surgical Kits KCT Class II General Hospital
2025-04-30 K250295 Dentsply Sirona Titanium Bases system NHA Class II Dental
2025-04-11 K250081 Atlantis® Abutments in Titanium NHA Class II Dental
2025-02-13 K243546 AH Plus Endodontic Sealer KIF — —
2024-12-17 K243336 Lucitone Digital Print Denture™ System EBI — —
2024-11-25 K241692 MIS LYNX Conical Connection Implant System DZE Class II Dental
2024-10-24 K242462 CEREC Cercon 4D CAD/CAM Blocks EIH Class II Dental
2024-08-28 K241557 Cercon® yo ML EIH Class II Dental
2024-07-24 K233865 X-Smart Pro; X-Smart Pro+ EKX Class I Dental
2024-05-07 K234018 CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System NHA Class II Dental
2024-04-02 K240888 Calibra Abutment Resin Cement EMA Class II Dental
2024-01-16 K231144 Washtrays KCT Class II General Hospital
2023-10-20 K231578 Lucitone Digital Print Denture System EBI — —
2023-10-18 K230199 Byte Aligner System NXC Class II Dental
2023-05-04 K223756 SimPro™ Now, GentleCath™ Hydrophilic EZD Class II Gastroenterology, Urology
2023-03-22 K221402 CEREC Tessera Abutment Block, CEREC Tessera Abutment System NHA Class II Dental
2022-11-16 K221094 OmniTaper EV Dental Implants, DS Implants abutments with EV connection DZE Class II Dental
2022-11-16 K220841 PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) DZE Class II Dental
2022-05-03 K220791 Surgical and Prosthetic Trays KCT Class II General Hospital
2022-04-01 K213432 MIS Angulated multi-unit abutments NHA Class II Dental
2022-03-04 K212281 Surgical Trays KCT Class II General Hospital
2022-02-17 K211212 LoFric Elle EZD Class II Gastroenterology, Urology
2021-11-15 K213449 DS Implants abutments provided with the EV connection NHA Class II Dental
2021-08-27 K210610 PrimeTaper EV Dental Implant DZE Class II Dental
2021-07-28 K211225 MIS Ti-base abutment NHA Class II Dental
2021-06-17 K210886 MIS Lance+ Conical Connection Dental Implant System DZE Class II Dental
2021-01-20 K202629 Dentsply Sirona Universal Spray Glazes EIH Class II Dental
2020-09-03 K200102 MIS Dental Implant System DZE Class II Dental
2020-09-02 K193405 Simplant Digital Guide NDP Class I Dental
2020-08-19 K200191 Sirona Dental CAD/CAM System with InLab Software PNP Class II Dental
2020-08-16 K193408 Sirona Dental CAD/CAM System with CEREC Chairside Software NHA Class II Dental
2020-07-06 K191152 MIS Ti-base Abutment NHA Class II Dental
2020-06-22 K201140 Axeos OAS Class II Radiology
2020-03-25 K193078 MIS CONNECT Conical Connection System NHA Class II Dental
2020-03-05 K193529 ATLANTIS Abutment for MIS Conical Connection Implants NHA Class II Dental
2020-03-03 K193064 Atlantis suprastructures NHA Class II Dental
2020-01-23 K192530 Surefil one Self-adhesive Composite Hybrid EMA Class II Dental
2020-01-13 K192409 Midwest Rhino XE and Air Motor M EFB — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence