FDA · official record K260722Substantially Equivalent

SureSmile Aligner (ASSY500020)

Name: SureSmile Aligner (ASSY500020) — FDA K260722
Creator: Dentsply Sirona, Inc.
Keywords: SureSmile Aligner (ASSY500020), SureSmile Aligner (ASSY500020), K260722, NXC, FDA

United StatesNXCDentsply Sirona, Inc.

Verified

Official record identity

FDA application number: K260722
Decision date: April 15, 2026
Published decision: Substantially Equivalent

Classification

Product code: NXC

Published parties

Applicant: Dentsply Sirona, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2026-03-05
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.5470

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.