ALIGN SYSTEM— 510(k) K981095

Substantially Equivalent

Align Technology

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

Clearance details

Applicant: Align Technology
Product code: Code NXC
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 ↗

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.