Medical Device Manufacturer · US , York , PA

Dentsply Sirona

64 submissions · 64 cleared · Since 2016
64
Total
64
Cleared
0
Denied

Dentsply Sirona — FDA 510(k) Submissions

Dentsply Sirona has submitted 64 FDA 510(k) premarket notifications since 2016, of which 64 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Abutment, Implant, Dental, Endosseous, Powder, Porcelain, Resin, Denture, Relining, Repairing, Rebasing, Implant, Endosseous, Root-form, System, Image Processing, Radiological . Use the specialty filter in the sidebar to narrow results.

64 devices
1–12 of 64
Primevision 3D
K253959 · OAS X-ray, Tomography,... · Radiology
Feb 2026 57d
Atlantis? Abutments in Titanium
K252343 · NHA Abutment, Implant,... · Dental
Dec 2025 134d
CEREC Tessera Abutment System
K252248 · NHA Abutment, Implant,... · Dental
Nov 2025 131d
Atlantis? Abutments in Titanium for Straumann BLX and Neodent GM Implants
K251205 · NHA Abutment, Implant,... · Dental
Nov 2025 217d
Dentsply Sirona Titanium Bases system
K250295 · NHA Abutment, Implant,... · Dental
Apr 2025 89d
Atlantis? Abutments in Titanium
K250081 · NHA Abutment, Implant,... · Dental
Apr 2025 88d
CEREC Cercon 4D CAD/CAM Blocks
K242462 · EIH Powder, Porcelain · Dental
Oct 2024 66d
Cercon? yo ML
K241557 · EIH Powder, Porcelain · Dental
Aug 2024 89d
CEREC Cercon 4D? Abutment Blocks, CEREC Cercon 4D? Abutment System
K234018 · NHA Abutment, Implant,... · Dental
May 2024 139d
Calibra Abutment Resin Cement
K240888 · EMA Cement, Dental · Dental
Apr 2024 1d
Washtrays
K231144 · KCT Sterilization Wrap... · General Hospital
Jan 2024 270d
Lucitone Digital Print Denture System
K231578 · EBI Resin, Denture, Relining,... · Dental
Oct 2023 142d

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