Invisalign System with Mandibular Advancement Featuring Occlusal Blocks— 510(k) K232233

Substantially Equivalent

Align Technology, Inc.

FDA 510(k) clearance K232233 for Invisalign System with Mandibular Advancement Featuring Occlusal Blocks, Substantially Equivalent on 2023-09-26. Applicant: Align Technology, Inc..

Clearance details

Applicant: Align Technology, Inc.
Product code: Code NXC
Advisory panel: Dental
Date received: 2023-07-27
Decision date: 2023-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, 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.