iTero Lumina™ Pro
by Align Technology Ltd. 510(k)
Active
510(k) K261847
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK261847 | Date2 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 25 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- NTK
- FDA applicant
- Align Technology , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.1745
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent