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

Cleared Mar 04, 2026

SureSmile Software

K253565 · PNN

Dental · 107d

Cleared Aug 29, 2025

Primescan 2

K250771 · NTK

Dental · 169d

Cleared Aug 25, 2025

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...

K251647 · DZE

Dental · 84d

Cleared Jul 24, 2025

MIS LYNX Conical Connection Implant System

K251297 · DZE

Dental · 87d

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

K241692 · DZE

Dental · 166d

Cleared Jul 24, 2024

X-Smart Pro

K233865 · EKX

Dental · 231d

Cleared Oct 18, 2023

Byte Aligner System

K230199 · NXC

Dental · 266d

Cleared Mar 22, 2023

CEREC Tessera Abutment Block, CEREC Tessera Abutment System

K221402 · NHA

Dental · 310d

Cleared Aug 27, 2021

PrimeTaper EV Dental Implant

K210610 · DZE

Dental · 179d