SureSmile Aligner (ASSY500020)— 510(k) K260722

Name: FDA 510(k) clearance K260722
Creator: U.S. Food and Drug Administration
Published: 2026-04-15

Substantially Equivalent

Dentsply Sirona, Inc.

FDA 510(k) clearance K260722 for SureSmile Aligner (ASSY500020), Substantially Equivalent on 2026-04-15. Applicant: Dentsply Sirona, Inc.. Device class: 2.

Summary

Dentsply Sirona's SureSmile Aligner (ASSY500020) is filed under product code NXC (Aligner, Sequential).

Class II, 21 CFR 872.5470. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Dentsply Sirona filed from York, Pennsylvania. The decision came 41 calendar days after FDA received it (March 5 to April 15, 2026).

Clearance details

Applicant: Dentsply Sirona, Inc.
Product code: Product code NXC
Device class: Class 2
Regulation: 21 CFR 872.5470
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 ↗

Recent devices under product code NXC

view all

K263860 — Shining3D Clear Aligner System2026-10-30
K260527 — FACE4D Aligner2026-07-02
K260788 — Smylio Aligners2026-05-08
K253282 — ZSmile System2026-02-03
K251454 — Clear Aligner (SCF-3348)2026-01-07

More clearances from Dentsply Sirona, Inc.

view all

K261072 — DS Core Detect2026-10-30
K261935 — Surgical and Prosthetic Trays2026-09-04
K253565 — SureSmile Software2026-03-04
K251614 — Stainless Steel Surgical Kits2026-02-06
K253009 — DS Core Detect2026-01-07

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.