Medical Device Manufacturer · US , York , PA

Dentsply Sirona, Inc. - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 2019

Recent clearances: DS Core Detect, Surgical and Prosthetic Trays, SureSmile Aligner (ASSY500020)

View 23 510(k) Devices ↓ Official Website

Total

Cleared

Denied

Dentsply Sirona, Inc. has 23 FDA 510(k) cleared medical devices. Based in York, US.

Latest FDA clearance: Oct 2026. Active since 2019. Primary specialty: Dental.

Browse the FDA 510(k) cleared devices submitted by Dentsply Sirona, Inc. Filter by specialty or product code using the sidebar.

Dentsply Sirona, Inc. is one of 25932 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Dentsply Sirona, Inc.

23 devices

1-23 of 23

Surgical and Prosthetic Trays

K261935 · KCT

General Hospital · 87d

Cleared Apr 15, 2026

SureSmile Aligner (ASSY500020)

Stainless Steel Surgical Kits

K251614 · KCT

General Hospital · 255d

Motor and Apex Module (MaAM)

K251811 · EBW

Dental · 74d

Cleared Aug 21, 2025

MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS...

MIS LYNX Conical Connection Implant System

K251297 · DZE

Dental · 87d

Cleared Jul 22, 2025

Plastic Surgical Kits

K251300 · KCT

General Hospital · 85d

Cleared Feb 13, 2025

AH Plus Endodontic Sealer

K243546 · KIF

Dental · 90d

Cleared Dec 17, 2024

Lucitone Digital Print Denture™ System

K243336 · EBI

Dental · 54d

Cleared Nov 25, 2024

MIS LYNX Conical Connection Implant System

CEREC Tessera Abutment Block, CEREC Tessera Abutment System

General Hospital · 226d

Cleared Aug 27, 2021

PrimeTaper EV Dental Implant

K210610 · DZE

Dental · 179d

Cleared Mar 03, 2020

Atlantis suprastructures

K193064 · NHA

Dental · 120d

Cleared Dec 11, 2019

MIS Dental Implant System

Dentsply Sirona, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Dentsply Sirona, Inc.

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