ALIGN SYSTEM— 510(k) K981095

Name: FDA 510(k) clearance K981095
Creator: U.S. Food and Drug Administration
Published: 1998-09-08

Substantially Equivalent

Align Technology

FDA 510(k) clearance K981095 for ALIGN SYSTEM, Substantially Equivalent on 1998-09-08. Applicant: Align Technology. Device class: 2.

Clearance details

Applicant: Align Technology
Product code: Code NXC
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 1998-03-26
Decision date: 1998-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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
K260722 — SureSmile Aligner (ASSY500020)2026-04-15
K253282 — ZSmile System2026-02-03
K251454 — Clear Aligner (SCF-3348)2026-01-07

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K081960 — INVISALIGN SYSTEM2008-12-17

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.