Dentsply Sirona, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Dentsply Sirona, Inc. - FDA 510(k) Cleared Devices
Recent clearances: SureSmile Aligner (ASSY500020), SureSmile Software, Stainless Steel Surgical Kits
21
Total
21
Cleared
0
Denied
Dentsply Sirona, Inc. has 21 FDA 510(k) cleared dental devices. Based in York, US.
Latest FDA clearance: Apr 2026. Active since 2019.
Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Dentsply Sirona, Inc.
21 devices
Cleared
Apr 15, 2026
SureSmile Aligner (ASSY500020)
Dental
41d
Cleared
Mar 04, 2026
SureSmile Software
Dental
107d
Cleared
Feb 06, 2026
Stainless Steel Surgical Kits
General Hospital
255d
Cleared
Jan 07, 2026
DS Core Detect
Radiology
110d
Cleared
Aug 29, 2025
Primescan 2
Dental
169d
Cleared
Aug 25, 2025
Motor and Apex Module (MaAM)
Dental
74d
Cleared
Aug 21, 2025
MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS...
Dental
84d
Cleared
Aug 12, 2025
DS Core Diagnosis
Radiology
153d
Cleared
Jul 24, 2025
MIS LYNX Conical Connection Implant System
Dental
87d
Cleared
Jul 22, 2025
Plastic Surgical Kits
General Hospital
85d
Cleared
Feb 13, 2025
AH Plus Endodontic Sealer
Dental
90d
Cleared
Dec 17, 2024
Lucitone Digital Print Denture™ System
Dental
54d
Cleared
Nov 25, 2024
MIS LYNX Conical Connection Implant System
Dental
166d
Cleared
Jul 24, 2024
X-Smart Pro
Dental
231d
Cleared
Oct 18, 2023
Byte Aligner System
Dental
266d
Cleared
Mar 22, 2023
CEREC Tessera Abutment Block, CEREC Tessera Abutment System
Dental
310d
Cleared
Mar 04, 2022
Surgical Trays
General Hospital
226d
Cleared
Aug 27, 2021
PrimeTaper EV Dental Implant
Dental
179d
Cleared
Mar 03, 2020
Atlantis suprastructures
Dental
120d
Cleared
Dec 11, 2019
MIS Dental Implant System
Dental
124d
Cleared
Jul 10, 2019
Conometric Abutments
Dental
247d