Dentsply Sirona - FDA 510(k) Cleared Devices
Recent clearances: DS Core CBCT Anatomy, Primevision 3D, Atlantis® Abutments in Titanium
65
Total
65
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dentsply Sirona Dental ✕
50 devices
Cleared
Dec 09, 2025
Atlantis® Abutments in Titanium
Dental
134d
Cleared
Nov 26, 2025
CEREC Tessera Abutment System
Dental
131d
Cleared
Nov 21, 2025
Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants
Dental
217d
Cleared
Apr 30, 2025
Dentsply Sirona Titanium Bases system
Dental
89d
Cleared
Apr 11, 2025
Atlantis® Abutments in Titanium
Dental
88d
Cleared
Oct 24, 2024
CEREC Cercon 4D CAD/CAM Blocks
Dental
66d
Cleared
Aug 28, 2024
Cercon® yo ML
Dental
89d
Cleared
May 07, 2024
CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System
Dental
139d
Cleared
Apr 02, 2024
Calibra Abutment Resin Cement
Dental
1d
Cleared
Oct 20, 2023
Lucitone Digital Print Denture System
Dental
142d
Cleared
Nov 16, 2022
PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection...
Dental
238d
Cleared
Nov 16, 2022
OmniTaper EV Dental Implants, DS Implants abutments with EV connection
Dental
216d
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