Dentsply Sirona, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
84
Inspections
8
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K253565SureSmile SoftwareMarch 4, 2026
K251614Stainless Steel Surgical KitsFebruary 6, 2026
K253959Primevision 3DFebruary 5, 2026
K253009DS Core DetectJanuary 7, 2026
K252343Atlantis® Abutments in TitaniumDecember 9, 2025
K252248CEREC Tessera Abutment SystemNovember 26, 2025
K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsNovember 21, 2025
K250771Primescan 2August 29, 2025
K251811Motor and Apex Module (MaAM)August 25, 2025
K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MAugust 21, 2025
K250755DS Core DiagnosisAugust 12, 2025
K251297MIS LYNX Conical Connection Implant SystemJuly 24, 2025
K251300Plastic Surgical KitsJuly 22, 2025
K250295Dentsply Sirona Titanium Bases systemApril 30, 2025
K250081Atlantis® Abutments in TitaniumApril 11, 2025
K243546AH Plus Endodontic SealerFebruary 13, 2025
K243336Lucitone Digital Print Denture™ SystemDecember 17, 2024
K241692MIS LYNX Conical Connection Implant SystemNovember 25, 2024
K242462CEREC Cercon 4D CAD/CAM BlocksOctober 24, 2024
K241557Cercon® yo MLAugust 28, 2024