Medical Device Manufacturer · US , York , PA

Dentsply Sirona, Inc.

20 submissions · 20 cleared · Since 2019
20
Total
20
Cleared
0
Denied

Dentsply Sirona, Inc. — FDA 510(k) Submissions

Dentsply Sirona, Inc. has submitted 20 FDA 510(k) premarket notifications since 2019, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Implant, Endosseous, Root-form, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, Abutment, Implant, Dental, Endosseous, Aligner, Sequential, Handpiece, Direct Drive, Ac-powered . Use the specialty filter in the sidebar to narrow results.

20 devices
1–20 of 20
SureSmile Software
K253565 · PNN Orthodontic Software · Dental
Mar 2026 107d
Stainless Steel Surgical Kits
K251614 · KCT Sterilization Wrap... · General Hospital
Feb 2026 255d
DS Core Detect
K253009 · MYN Analyzer, Medical Image · Radiology
Jan 2026 110d
Primescan 2
K250771 · NTK Caries Detector, Laser... · Dental
Aug 2025 169d
Motor and Apex Module (MaAM)
K251811 · EBW Controller, Foot,... · Dental
Aug 2025 74d
MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System
K251647 · DZE Implant, Endosseous,... · Dental
Aug 2025 84d
DS Core Diagnosis
K250755 · QIH Automated Radiological... · Radiology
Aug 2025 153d
MIS LYNX Conical Connection Implant System
K251297 · DZE Implant, Endosseous,... · Dental
Jul 2025 87d
Plastic Surgical Kits
K251300 · KCT Sterilization Wrap... · General Hospital
Jul 2025 85d
AH Plus Endodontic Sealer
K243546 · KIF Resin, Root Canal Filling · Dental
Feb 2025 90d
Lucitone Digital Print Denture? System
K243336 · EBI Resin, Denture, Relining,... · Dental
Dec 2024 54d
MIS LYNX Conical Connection Implant System
K241692 · DZE Implant, Endosseous,... · Dental
Nov 2024 166d
X-Smart Pro; X-Smart Pro+
K233865 · EKX Handpiece, Direct Drive,... · Dental
Jul 2024 231d
Byte Aligner System
K230199 · NXC Aligner, Sequential · Dental
Oct 2023 266d
CEREC Tessera Abutment Block, CEREC Tessera Abutment System
K221402 · NHA Abutment, Implant,... · Dental
Mar 2023 310d
Surgical Trays
K212281 · KCT Sterilization Wrap... · General Hospital
Mar 2022 226d
PrimeTaper EV Dental Implant
K210610 · DZE Implant, Endosseous,... · Dental
Aug 2021 179d
Atlantis suprastructures
K193064 · NHA Abutment, Implant,... · Dental
Mar 2020 120d
MIS Dental Implant System
K192149 · DZE Implant, Endosseous,... · Dental
Dec 2019 124d
Conometric Abutments
K183079 · NHA Abutment, Implant,... · Dental
Jul 2019 247d
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