Invisalign System— 510(k) K143630
Substantially EquivalentAlign Technology, Inc.
FDA 510(k) clearance K143630 for Invisalign System, Substantially Equivalent on 2015-11-18. Applicant: Align Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Align Technology, Inc.
- Product code
- Code NXC
- Device class
- Class 2
- Regulation
- 21 CFR 872.5470
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code NXC
view allMore clearances from Align Technology, Inc.
view allAdverse events under product code NXC
product code NXC- Injury
- 15,206
- Malfunction
- 2,576
- Other
- 9
- Total
- 17,791
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.