ITERO SOFTWARE— 510(k) K131101

Name: FDA 510(k) clearance K131101
Creator: U.S. Food and Drug Administration
Published: 2013-08-26

Substantially Equivalent

Cadent, Ltd. an Align Technology Company

FDA 510(k) clearance K131101 for ITERO SOFTWARE, Substantially Equivalent on 2013-08-26. Applicant: Cadent, Ltd. an Align Technology Company. Device class: 2.

Clearance details

Applicant: Cadent, Ltd. an Align Technology Company
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2013-04-19
Decision date: 2013-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

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.