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.

Clearance details

Applicant: Dentsply Sirona, Inc.
Product code: 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

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K260527 — FACE4D Aligner2026-07-02
K260788 — Smylio Aligners2026-05-08
K253282 — ZSmile System2026-02-03
K251454 — Clear Aligner (SCF-3348)2026-01-07
K250739 — Primeprint Direct Aligner2025-11-07

More clearances from Dentsply Sirona, Inc.

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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
K250771 — Primescan 22025-08-29

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.