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Dentsply Sirona, Inc.

21 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
SureSmile Aligner (ASSY500020) (K260722)Dentsply Sirona, Inc.2026-04-15
SureSmile Software (K253565)Dentsply Sirona, Inc.2026-03-04
Stainless Steel Surgical Kits (K251614)Dentsply Sirona, Inc.2026-02-06
DS Core Detect (K253009)Dentsply Sirona, Inc.2026-01-07
Primescan 2 (K250771)Dentsply Sirona, Inc.2025-08-29
Motor and Apex Module (MaAM) (K251811)Dentsply Sirona, Inc.2025-08-25
MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System (K251647)Dentsply Sirona, Inc.2025-08-21
DS Core Diagnosis (K250755)Dentsply Sirona, Inc.2025-08-12
MIS LYNX Conical Connection Implant System (K251297)Dentsply Sirona, Inc.2025-07-24
Plastic Surgical Kits (K251300)Dentsply Sirona, Inc.2025-07-22
AH Plus Endodontic Sealer (K243546)Dentsply Sirona, Inc.2025-02-13
Lucitone Digital Print Denture™ System (K243336)Dentsply Sirona, Inc.2024-12-17
MIS LYNX Conical Connection Implant System (K241692)Dentsply Sirona, Inc.2024-11-25
X-Smart Pro; X-Smart Pro+ (K233865)Dentsply Sirona, Inc.2024-07-24
Byte Aligner System (K230199)Dentsply Sirona, Inc.2023-10-18
CEREC Tessera Abutment Block, CEREC Tessera Abutment System (K221402)Dentsply Sirona, Inc.2023-03-22
Surgical Trays (K212281)Dentsply Sirona, Inc.2022-03-04
PrimeTaper EV Dental Implant (K210610)Dentsply Sirona, Inc.2021-08-27
Atlantis suprastructures (K193064)Dentsply Sirona, Inc.2020-03-03
MIS Dental Implant System (K192149)Dentsply Sirona, Inc.2019-12-11
Conometric Abutments (K183079)Dentsply Sirona, Inc.2019-07-10

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Every clearance here is in the API, with alerts when new ones post.