510(k) clearance
Invisalign System
- 510(k) number
- K262196
- Applicant
- Align Technology, Inc.
- Decision date
- Sep 25, 2026
- Date received
- Jun 29, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PNN
- Device type
- Orthodontic Software
- Device class
- Class II
- Regulation
- 21 CFR 872.5470
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- San Jose, CA, US