SureSmile Aligner (ASSY500020)
K-Number: K260722 · 2026-04-15
ApplicantDentsply Sirona, Inc.
Decision Date2026-04-15
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SureSmile Aligner (ASSY500020) is a medical device manufactured by Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2026-04-15 under approval number K260722. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SureSmile Aligner (ASSY500020)?
SureSmile Aligner (ASSY500020) is a medical device that received FDA 510(k) clearance on 2026-04-15. It is manufactured by Dentsply Sirona, Inc.. The 510(k) number is K260722.
When was SureSmile Aligner (ASSY500020) approved by the FDA?
SureSmile Aligner (ASSY500020) received FDA 510(k) clearance on 2026-04-15, under approval number K260722.
What company makes SureSmile Aligner (ASSY500020)?
SureSmile Aligner (ASSY500020) is manufactured by Dentsply Sirona, Inc..
What is the FDA product code for SureSmile Aligner (ASSY500020)?
The FDA product code for SureSmile Aligner (ASSY500020) is NXC.
Other Devices by Dentsply Sirona, Inc.
Related Devices (Code: NXC)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.