Dentsply Sirona, Inc.
Dentsply Sirona, Inc. holds FDA 510(k) medical device clearances, first cleared 2019, most recent 2026.
Top product codes for Dentsply Sirona, Inc.
Recent clearances by Dentsply Sirona, Inc.
- K261935 — Surgical and Prosthetic Trays
- K260722 — SureSmile Aligner (ASSY500020)
- K253565 — SureSmile Software
- K251614 — Stainless Steel Surgical Kits
- K253009 — DS Core Detect
- K250771 — Primescan 2
- K251811 — Motor and Apex Module (MaAM)
- K251647 — MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System
- K250755 — DS Core Diagnosis
- K251297 — MIS LYNX Conical Connection Implant System
- K251300 — Plastic Surgical Kits
- K243546 — AH Plus Endodontic Sealer
- K243336 — Lucitone Digital Print Denture System
- K241692 — MIS LYNX Conical Connection Implant System
- K233865 — X-Smart Pro; X-Smart Pro+
- K230199 — Byte Aligner System
- K221402 — CEREC Tessera Abutment Block, CEREC Tessera Abutment System
- K212281 — Surgical Trays
- K210610 — PrimeTaper EV Dental Implant
- K193064 — Atlantis suprastructures
- K192149 — MIS Dental Implant System
- K183079 — Conometric Abutments
Data sourced from openFDA. This site is unofficial and independent of the FDA.