SureSmile Aligner (ASSY500020)— 510(k) K260722

Substantially Equivalent

Dentsply Sirona, Inc.

FDA 510(k) clearance K260722 for SureSmile Aligner (ASSY500020), Substantially Equivalent on 2026-04-15. Applicant: Dentsply Sirona, Inc..

Clearance details

Applicant: Dentsply Sirona, Inc.
Product code: Code NXC
Advisory panel: Dental
Date received: 2026-03-05
Decision date: 2026-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NXC

product code NXC

Injury: 15,206
Malfunction: 2,576
Other: 9
Total: 17,791

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.