ITERO SOFTWARE— 510(k) K131101
Substantially EquivalentCadent, 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.
Clearance details
- Applicant
- Cadent, Ltd. an Align Technology Company
- Product code
- Code NHA
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Adverse events under product code NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
Source: openFDA MAUDE database, through . 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.