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Dentsply Sirona, Inc.

FDA 510(k) & PMA Approved Devices — 21 products

Total Devices21
Categories12
Latest Approval2026-04-15
TypeNumberDevice NameCodeDate
510(k) K260722 SureSmile Aligner (ASSY500020) NXC 2026-04-15 View
510(k) K253565 SureSmile Software PNN 2026-03-04 View
510(k) K251614 Stainless Steel Surgical Kits KCT 2026-02-06 View
510(k) K253009 DS Core Detect MYN 2026-01-07 View
510(k) K250771 Primescan 2 NTK 2025-08-29 View
510(k) K251811 Motor and Apex Module (MaAM) EBW 2025-08-25 View
510(k) K251647 MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System DZE 2025-08-21 View
510(k) K250755 DS Core Diagnosis QIH 2025-08-12 View
510(k) K251297 MIS LYNX Conical Connection Implant System DZE 2025-07-24 View
510(k) K251300 Plastic Surgical Kits KCT 2025-07-22 View
510(k) K243546 AH Plus Endodontic Sealer KIF 2025-02-13 View
510(k) K243336 Lucitone Digital Print Denture™ System EBI 2024-12-17 View
510(k) K241692 MIS LYNX Conical Connection Implant System DZE 2024-11-25 View
510(k) K233865 X-Smart Pro; X-Smart Pro+ EKX 2024-07-24 View
510(k) K230199 Byte Aligner System NXC 2023-10-18 View
510(k) K221402 CEREC Tessera Abutment Block, CEREC Tessera Abutment System NHA 2023-03-22 View
510(k) K212281 Surgical Trays KCT 2022-03-04 View
510(k) K210610 PrimeTaper EV Dental Implant DZE 2021-08-27 View
510(k) K193064 Atlantis suprastructures NHA 2020-03-03 View
510(k) K192149 MIS Dental Implant System DZE 2019-12-11 View

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